Clinical Trials List
Protocol NumberDCSZ11-101
Active
2024-07-15 - 2026-08-31
Phase I
Recruiting5
ICD-10C34.90
Malignant neoplasm of unspecified part of unspecified bronchus or lung
ICD-10C34.91
Malignant neoplasm of unspecified part of right bronchus or lung
ICD-10C34.92
Malignant neoplasm of unspecified part of left bronchus or lung
ICD-10C7A.090
Malignant carcinoid tumor of the bronchus and lung
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9162.9
Malignant neoplasm of bronchus and lung, unspecified
A Phase 1, Multicenter, Open-Label, Dose Escalation, and Dose Expansion Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of DCSZ11 as a Monotherapy and in Combination in Patients with Advanced or Metastatic Solid Tumors
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Trial Applicant
-
Sponsor
DynamiCure Biotechnology, LLC
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chun-Jen Liu Division of General Internal Medicine
- 施怡倫 Division of Radiology
- KAI-WEN HUANG Division of General Surgery
- Chih-Hung Hsu Division of Hematology & Oncology
- 楊宏志 Division of General Internal Medicine
- JA-DER LIANG Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chi-Lu Chiang Division of Thoracic Medicine
- 唐振育 Division of Thoracic Medicine
- Hao-Wei Teng Division of Hematology & Oncology
- 姜乃榕 Division of Thoracic Medicine
- San-Chi Chen Division of Thoracic Medicine
- Jiun-I Lai Division of Hematology & Oncology
- Chien-An Liu Division of Thoracic Medicine
- Tien-Hua Chen Division of Thoracic Medicine
- Chueh-Chuan Yen Division of Hematology & Oncology
- Yi-Ping Hung Division of Thoracic Medicine
- Yung-Hung Luo Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Lung Yu Digestive System Department
- Chung-Feng Huang Digestive System Department
- 梁博程 Digestive System Department
- Ming-Lun Yeh Digestive System Department
- Wan-Long Chuang Digestive System Department
- Chia-Yen Dai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-Hui Lee 無
- Shang-Hung Chen 無
- Yu-Min Yeh 無
- Chian-Wei Chen 無
- 蔡政軒 無
- Chiu Hung Chiu 無
- Yu-Fang Huang 無
- Wu-Chou Su 無
- Shang-Yin Wu 無
- Chin-Wei Kuo 無
- Seu-Chun Yang 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
kang-Yun LEE
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced or Metastatic Solid Tumors
Objectives
Phase 1a Parts 1 and 2: Dose Escalation
• To assess the safety and tolerability of DCSZ11 as
monotherapy and in combination with pembrolizumab
Test Drug
injection
Active Ingredient
DCSZ11
Dosage Form
270
Dosage
400mg/8mL
Endpoints
Phase 1a, Parts 1 and 2: Dose Escalation
● Incidence of dose-limiting toxicities (DLTs) within the first 21 days after DCSZ11 administration.
● Frequency and severity of treatment-related adverse events (TEAEs).
Phase 1a: Dose Escalation Expansion
● Overall response rate (ORR) as assessed by the trial administrator according to the Recognition of Solid Tumor Response Standards, Version 1.1 (RECIST) or the Neuro-Oncology Response Assessment (RANO).
Phase 1b: Dose Expansion/Optimization
● ORR as assessed by the trial administrator according to RECIST.
● Incidence of dose-limiting toxicities (DLTs) within the first 21 days after DCSZ11 administration.
● Frequency and severity of treatment-related adverse events (TEAEs).
Phase 1a: Dose Escalation Expansion
● Overall response rate (ORR) as assessed by the trial administrator according to the Recognition of Solid Tumor Response Standards, Version 1.1 (RECIST) or the Neuro-Oncology Response Assessment (RANO).
Phase 1b: Dose Expansion/Optimization
● ORR as assessed by the trial administrator according to RECIST.
Inclution Criteria
Key Inclusion Criteria:
1. Male or female patients aged ≥ 18 years.
2. Willing and able to provide written informed consent for the trial.
3. Stage 1a patients must meet one of the following criteria:
Possessing histologically or cytologically confirmed advanced (metastatic and/or unresectable) solid tumors that have progressed during or after standard treatment (relapsed/refractory patients; patients must have failed at least one first-line therapy).
Or, as determined by the trial administrator, there is no feasible standard treatment.
Notes:
Patients with glioblastoma (GBM) or other central nervous system (CNS) tumors are eligible to participate if their corticosteroid dose is stable or reduced within 7 days prior to receiving the first dose of the investigational drug, and does not exceed 2 mg/day of dexamethasone (or an equivalent dose of another corticosteroid), or if they do not require corticosteroids.
For patients who cannot tolerate or refuse standard treatment for relapsed disease, the reason must be recorded.
4. Patients in the stage 1b dose optimization/expansion group must meet one of the following criteria:
a. Non-squamous non-small cell lung cancer (NSCLC) meeting the following conditions:
Prior first-line treatment with a standard single or combined therapy containing an anti-programmed cell death protein 1/ligand 1 (PD-(1/L1)) checkpoint inhibitor failed.
Received no more than two lines of systemic therapy and did not experience disease progression within the first 3 months of first-line PD-(1/L1) therapy.
According to RECIST 1.1, disease progression must be recorded within 12 weeks of the last dose of an anti-PD-1/L1 monoclonal antibody (mAb) to be considered a failure of anti-PD-(1/L1) mAb therapy.
Initial disease progression following anti-PD-1/L1 mAb therapy must be confirmed by a second evaluation at least 4 weeks after the initial confirmation.
Notes:
* Patients with known driver mutations/gene aberrations (i.e., epidermal growth factor receptor [EGFR], BRAF V600E proto-oncogene mutation, ROS1 sensitization mutation, neurotrophic receptor tyrosine kinase [NRTK] gene fusion, and ALK gene recombination) are ineligible.
* Patients with rapidly progressing clinical disease are not eligible for the trial.
b. Microsatellite stable colorectal cancer (MSS-CRC) that has not received prior immunotherapy and meets the following criteria:
* Failure or intolerance to at least two lines of therapy, and disease progression after no more than four lines of therapy.
Notes:
* If applicable, patients must have previously received treatment with fluoropyrimidine, oxaliplatin, or irinotecan.
* If the patient is eligible for approved and available targeted therapy, a recommendation for such treatment must be provided prior to enrollment.
• If a patient's disease progresses during adjuvant chemotherapy or within 6 months of completion, this treatment will be considered first-line therapy.
5. Patients in the stage 1b standard treatment plus introduction/amplification group must meet one of the following criteria:
a. Histologically confirmed metastatic or locally advanced, unresectable soft tissue sarcoma that has not been treated with anthracyclines and is eligible for doxorubicin monotherapy.
Note: Evans sarcoma, gastrointestinal stromal tumors (GIST), and Kaposi's sarcoma are excluded.
b. Histologically confirmed metastatic or locally advanced, unresectable uveal melanoma that is eligible for tebentafusp monotherapy. Patients should not receive more than 4 doses of the target 68 mcg dose of tebentafusp.
6. Patients must meet the following criteria:
Have a lesion that has not previously received radiation therapy and is undergoing biopsy at an acceptable clinical risk level, and agree to have one fresh biopsy taken during screening and treatment;
This criterion does not apply to patients with GBM or other CNS tumors.
A second biopsy should be obtained from the same lesion as the one taken at screening.
7. Patients must meet the following criteria:
Have at least one measurable lesion as assessed according to RECIST 1.1; this criterion does not apply to patients in the monotherapy level 1 and 2 dose groups.
a. Lesions at previously radiation-treated sites can be considered measurable disease, provided there is objective evidence of disease progression prior to inclusion in the trial.
b. Patients must have at least one measurable lesion for inclusion in the trial, and this lesion will not be biopsied.
c. For GBM patients, the T1-weighted imaging of the primary tumor after contrast imaging must meet the definition of measurable disease according to the Neuro-Oncology Response Assessment (RANO) criteria. 8. Patients previously treated for CNS metastases are eligible to participate in the trial provided that:
a. the metastases are stable (i.e., no evidence of disease progression on MRI within at least 4 weeks prior to the first dose of the investigational drug), and
b. all neurological symptoms have returned to baseline, and
c. for patients enrolled in the expanded group, they have not received steroid treatment for at least 14 days prior to receiving the first dose of the investigational intervention.
Patients with suspected symptoms or signs of CNS metastases must undergo brain imaging within 2 weeks prior to the first dose of the investigational drug to confirm the absence of detectable CNS disease.
Note: This condition does not apply to patients with GBM or other CNS tumors.
9. The East Coast Cancer Clinical Research Consortium (ECOG) performance status score is between 0 and 2. Patients enrolled in the expanded group must have an ECOG performance status score of 0 or 1.
10. Patients must have adequate organ function and bone marrow reserve within 10 days prior to the first dose of the investigational drug, as indicated by the following laboratory assessments:
a. Bone marrow function:
Absolute neutrophil count (ANC) ≥ 1000/µL, ANC ≥ 1500/µL for the amplification group;
Heme ≥ 9 g/dL (must meet the criteria of being erythropoietin-independent and having not received pRBC transfusion within the past 2 weeks);
Platelet count ≥ 75,000/µL, platelet count ≥ 100,000/µL for the amplification group.
b. Liver Function:
Total serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), or for patients with total bilirubin concentration > 1.5 times ULN, direct bilirubin ≤ ULN;
Serum aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present).
Note: For patients with hereditary bilirubin metabolism disorders, this should be discussed with the trial commissioner.
c. Renal Function: Creatinine clearance ≥ 30 mL/min, calculated based on Cockcroft-Gault estimates.
d. Coagulation Profile:
Prothrombin time (PT) – International Normalized Ratio (INR)/Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times ULN.
• For patients who have received stable anticoagulation therapy for at least 30 days prior to the first dose of the investigational drug, their PT/INR measurement may exceed 1.5 times the ULN if the trial administrator deems them suitable for participation, provided a full explanation is provided and approved by the trial commissioner.
11. All toxicities associated with prior treatment have regressed to Grade 1 or the baseline period, or have been confirmed as sequelae.
Note: Grade 2 or lower neuropathy and/or hearing impairment, any grade of hair loss, or autoimmune endocrine abnormalities under stable replacement therapy are permissible.
12. Patients receiving and using standard therapy must meet the established treatment criteria for the corresponding standard therapy drug.
13. Patients infected with human immunodeficiency virus (HIV) must have achieved good disease control after receiving antiretroviral therapy (ART), defined as follows:
a. At screening, patients receiving ART must have a CD4+ T cell count ≥ 350 cells/mm3.
b. Patients receiving ART must have achieved and maintained viral suppression, defined as follows:
• At the time of screening and for at least 12 weeks prior, HIV RNA concentrations confirmed to be below 50 or below the detection limit (LLOQ) using locally available testing methods.
c. Patients receiving ART must have maintained a stable course of treatment for at least 4 weeks prior to the start of the trial (Day 1), without changing medications or adjusting dosages, and agree to continue receiving ART throughout the trial.
d. Patients must not have had any opportunistic infections with a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) in the past 12 months, and must not have a history of Kaposi's sarcoma and/or multicentric Kaseman's disease.
14. Female patients must agree not to breastfeed for 5 months after receiving the last dose of the investigational drug and must meet one of the following criteria:
a. Have been menopausal for at least one year prior to the screening visit; or
b. Have undergone surgical sterilization; or
c. Agree to use one effective (barrier) contraceptive method in addition to a highly effective method of contraception from the date of signing the Intended Contraceptive Form (ICF) until 5 months after the last dose of the investigational drug; or
d. Agree to complete abstinence throughout the entire trial treatment period and for 5 months after the last dose of the investigational drug, provided that the patient's daily lifestyle is consistent with this.
The following methods are not considered acceptable methods of contraception: periodic abstinence [e.g., cycle method, ovulation tracking method, basal body temperature method, post-ovulation contraception], withdrawal method, spermicide-only method, and lactational amenorrhea method, etc. Female and male condoms should not be used simultaneously.
15. Even if the male patient has undergone surgical sterilization (i.e., vasectomy), he/she must still meet one of the following criteria:
a. Agree to use an effective barrier method of contraception from the date of signing the ICF until two months after the last dose of DCSZ11, or
b. Agree to complete abstinence from sex from the date of signing the ICF until two months after the last dose of the experimental drug, provided that the patient's daily lifestyle is consistent with this.
The following methods are not considered acceptable methods of contraception: periodic abstinence [e.g., cycle method, ovulation tracking method, basal body temperature method, post-ovulation contraception], withdrawal method, spermicide-only method, and lactational amenorrhea method, etc. Female and male condoms should not be used simultaneously.
16. Patients must be willing and able to follow the clinic visits and procedures outlined in the trial protocol.
1. Male or female patients aged ≥ 18 years.
2. Willing and able to provide written informed consent for the trial.
3. Stage 1a patients must meet one of the following criteria:
Possessing histologically or cytologically confirmed advanced (metastatic and/or unresectable) solid tumors that have progressed during or after standard treatment (relapsed/refractory patients; patients must have failed at least one first-line therapy).
Or, as determined by the trial administrator, there is no feasible standard treatment.
Notes:
Patients with glioblastoma (GBM) or other central nervous system (CNS) tumors are eligible to participate if their corticosteroid dose is stable or reduced within 7 days prior to receiving the first dose of the investigational drug, and does not exceed 2 mg/day of dexamethasone (or an equivalent dose of another corticosteroid), or if they do not require corticosteroids.
For patients who cannot tolerate or refuse standard treatment for relapsed disease, the reason must be recorded.
4. Patients in the stage 1b dose optimization/expansion group must meet one of the following criteria:
a. Non-squamous non-small cell lung cancer (NSCLC) meeting the following conditions:
Prior first-line treatment with a standard single or combined therapy containing an anti-programmed cell death protein 1/ligand 1 (PD-(1/L1)) checkpoint inhibitor failed.
Received no more than two lines of systemic therapy and did not experience disease progression within the first 3 months of first-line PD-(1/L1) therapy.
According to RECIST 1.1, disease progression must be recorded within 12 weeks of the last dose of an anti-PD-1/L1 monoclonal antibody (mAb) to be considered a failure of anti-PD-(1/L1) mAb therapy.
Initial disease progression following anti-PD-1/L1 mAb therapy must be confirmed by a second evaluation at least 4 weeks after the initial confirmation.
Notes:
* Patients with known driver mutations/gene aberrations (i.e., epidermal growth factor receptor [EGFR], BRAF V600E proto-oncogene mutation, ROS1 sensitization mutation, neurotrophic receptor tyrosine kinase [NRTK] gene fusion, and ALK gene recombination) are ineligible.
* Patients with rapidly progressing clinical disease are not eligible for the trial.
b. Microsatellite stable colorectal cancer (MSS-CRC) that has not received prior immunotherapy and meets the following criteria:
* Failure or intolerance to at least two lines of therapy, and disease progression after no more than four lines of therapy.
Notes:
* If applicable, patients must have previously received treatment with fluoropyrimidine, oxaliplatin, or irinotecan.
* If the patient is eligible for approved and available targeted therapy, a recommendation for such treatment must be provided prior to enrollment.
• If a patient's disease progresses during adjuvant chemotherapy or within 6 months of completion, this treatment will be considered first-line therapy.
5. Patients in the stage 1b standard treatment plus introduction/amplification group must meet one of the following criteria:
a. Histologically confirmed metastatic or locally advanced, unresectable soft tissue sarcoma that has not been treated with anthracyclines and is eligible for doxorubicin monotherapy.
Note: Evans sarcoma, gastrointestinal stromal tumors (GIST), and Kaposi's sarcoma are excluded.
b. Histologically confirmed metastatic or locally advanced, unresectable uveal melanoma that is eligible for tebentafusp monotherapy. Patients should not receive more than 4 doses of the target 68 mcg dose of tebentafusp.
6. Patients must meet the following criteria:
Have a lesion that has not previously received radiation therapy and is undergoing biopsy at an acceptable clinical risk level, and agree to have one fresh biopsy taken during screening and treatment;
This criterion does not apply to patients with GBM or other CNS tumors.
A second biopsy should be obtained from the same lesion as the one taken at screening.
7. Patients must meet the following criteria:
Have at least one measurable lesion as assessed according to RECIST 1.1; this criterion does not apply to patients in the monotherapy level 1 and 2 dose groups.
a. Lesions at previously radiation-treated sites can be considered measurable disease, provided there is objective evidence of disease progression prior to inclusion in the trial.
b. Patients must have at least one measurable lesion for inclusion in the trial, and this lesion will not be biopsied.
c. For GBM patients, the T1-weighted imaging of the primary tumor after contrast imaging must meet the definition of measurable disease according to the Neuro-Oncology Response Assessment (RANO) criteria. 8. Patients previously treated for CNS metastases are eligible to participate in the trial provided that:
a. the metastases are stable (i.e., no evidence of disease progression on MRI within at least 4 weeks prior to the first dose of the investigational drug), and
b. all neurological symptoms have returned to baseline, and
c. for patients enrolled in the expanded group, they have not received steroid treatment for at least 14 days prior to receiving the first dose of the investigational intervention.
Patients with suspected symptoms or signs of CNS metastases must undergo brain imaging within 2 weeks prior to the first dose of the investigational drug to confirm the absence of detectable CNS disease.
Note: This condition does not apply to patients with GBM or other CNS tumors.
9. The East Coast Cancer Clinical Research Consortium (ECOG) performance status score is between 0 and 2. Patients enrolled in the expanded group must have an ECOG performance status score of 0 or 1.
10. Patients must have adequate organ function and bone marrow reserve within 10 days prior to the first dose of the investigational drug, as indicated by the following laboratory assessments:
a. Bone marrow function:
Absolute neutrophil count (ANC) ≥ 1000/µL, ANC ≥ 1500/µL for the amplification group;
Heme ≥ 9 g/dL (must meet the criteria of being erythropoietin-independent and having not received pRBC transfusion within the past 2 weeks);
Platelet count ≥ 75,000/µL, platelet count ≥ 100,000/µL for the amplification group.
b. Liver Function:
Total serum bilirubin ≤ 1.5 times the upper limit of normal (ULN), or for patients with total bilirubin concentration > 1.5 times ULN, direct bilirubin ≤ ULN;
Serum aspartate transaminase (AST)/alanine transaminase (ALT) ≤ 2.5 times ULN (≤ 5 times ULN if liver metastasis is present).
Note: For patients with hereditary bilirubin metabolism disorders, this should be discussed with the trial commissioner.
c. Renal Function: Creatinine clearance ≥ 30 mL/min, calculated based on Cockcroft-Gault estimates.
d. Coagulation Profile:
Prothrombin time (PT) – International Normalized Ratio (INR)/Activated Partial Thromboplastin Time (aPTT) ≤ 1.5 times ULN.
• For patients who have received stable anticoagulation therapy for at least 30 days prior to the first dose of the investigational drug, their PT/INR measurement may exceed 1.5 times the ULN if the trial administrator deems them suitable for participation, provided a full explanation is provided and approved by the trial commissioner.
11. All toxicities associated with prior treatment have regressed to Grade 1 or the baseline period, or have been confirmed as sequelae.
Note: Grade 2 or lower neuropathy and/or hearing impairment, any grade of hair loss, or autoimmune endocrine abnormalities under stable replacement therapy are permissible.
12. Patients receiving and using standard therapy must meet the established treatment criteria for the corresponding standard therapy drug.
13. Patients infected with human immunodeficiency virus (HIV) must have achieved good disease control after receiving antiretroviral therapy (ART), defined as follows:
a. At screening, patients receiving ART must have a CD4+ T cell count ≥ 350 cells/mm3.
b. Patients receiving ART must have achieved and maintained viral suppression, defined as follows:
• At the time of screening and for at least 12 weeks prior, HIV RNA concentrations confirmed to be below 50 or below the detection limit (LLOQ) using locally available testing methods.
c. Patients receiving ART must have maintained a stable course of treatment for at least 4 weeks prior to the start of the trial (Day 1), without changing medications or adjusting dosages, and agree to continue receiving ART throughout the trial.
d. Patients must not have had any opportunistic infections with a diagnosis of Acquired Immunodeficiency Syndrome (AIDS) in the past 12 months, and must not have a history of Kaposi's sarcoma and/or multicentric Kaseman's disease.
14. Female patients must agree not to breastfeed for 5 months after receiving the last dose of the investigational drug and must meet one of the following criteria:
a. Have been menopausal for at least one year prior to the screening visit; or
b. Have undergone surgical sterilization; or
c. Agree to use one effective (barrier) contraceptive method in addition to a highly effective method of contraception from the date of signing the Intended Contraceptive Form (ICF) until 5 months after the last dose of the investigational drug; or
d. Agree to complete abstinence throughout the entire trial treatment period and for 5 months after the last dose of the investigational drug, provided that the patient's daily lifestyle is consistent with this.
The following methods are not considered acceptable methods of contraception: periodic abstinence [e.g., cycle method, ovulation tracking method, basal body temperature method, post-ovulation contraception], withdrawal method, spermicide-only method, and lactational amenorrhea method, etc. Female and male condoms should not be used simultaneously.
15. Even if the male patient has undergone surgical sterilization (i.e., vasectomy), he/she must still meet one of the following criteria:
a. Agree to use an effective barrier method of contraception from the date of signing the ICF until two months after the last dose of DCSZ11, or
b. Agree to complete abstinence from sex from the date of signing the ICF until two months after the last dose of the experimental drug, provided that the patient's daily lifestyle is consistent with this.
The following methods are not considered acceptable methods of contraception: periodic abstinence [e.g., cycle method, ovulation tracking method, basal body temperature method, post-ovulation contraception], withdrawal method, spermicide-only method, and lactational amenorrhea method, etc. Female and male condoms should not be used simultaneously.
16. Patients must be willing and able to follow the clinic visits and procedures outlined in the trial protocol.
Exclusion Criteria
Key exclusion criteria:
1. Received systemic antitumor therapy or the investigational drug (whichever is shorter) within 28 days or 5 half-lives prior to the first dose of the investigational drug.
Note: Low-dose steroids (oral prednisone ≤ 10 mg daily or equivalent), hormone therapy for prostate or breast cancer (as adjuvant therapy), bisphosphonates, and RANKL inhibitors are all acceptable.
2. Received extensive radiation therapy ≤ 4 weeks prior to treatment initiation, or received palliative localized radiation therapy outside the chest or brain within ≤ 7 days prior to treatment initiation, or requires corticosteroid therapy due to radiation-related toxicity.
3. Patients diagnosed with a second malignant tumor within the past 3 years are ineligible for the trial, except in the following cases:
* Treated basal cell or localized squamous cell carcinoma of the skin
* Localized prostate cancer
* Cervical cancer in situ
* Resected colorectal adenomatous polyps
* Breast cancer in situ
* Other malignant tumors not currently receiving anti-tumor therapy.
Patients meeting these exceptions must be discussed with the trial commissioner before inclusion in the trial.
4. Patients with known active CNS metastases and/or carcinomatous meningitis.
5. Patients who have experienced a systemic arterial thrombotic or embolic event, such as a cerebrovascular accident (including ischemic attack) or hemoptysis, within 3 months prior to the first dose of the investigational drug.
6. Patients who have experienced a systemic venous thrombotic event (e.g., deep vein thrombosis) or a pulmonary artery event (e.g., pulmonary embolism) within 1 month prior to the first dose of the investigational drug. However, patients are eligible if they experienced a venous thrombotic event before receiving the first dose of the investigational drug and have been receiving stable anticoagulation therapy.
7. Left ventricular ejection ratio (LVEF) < 50%.
8. Major surgery within 4 weeks prior to the first dose of the investigational drug, and minor surgery within 2 weeks prior; all surgical wounds must have healed without infection or dehiscence. Patients must have fully recovered and have no ongoing surgical complications.
9. Significant proteinuria ≥ 2 g/24 hours, and/or nephrotic syndrome. If a patient's urine test strip shows 2+ or higher proteinuria, further evaluation, such as 24-hour urine collection, should be performed.
10. Known hypersensitivity or severe hypersensitivity to any component of the investigational drug, or, for patients receiving contrast agents, hypersensitivity to any component of the contrast agent.
11. For patients receiving pembrolizumab in combination:
a. Prior to any immunotherapy, treatment was discontinued due to a grade 3 or higher immune-related adverse event (excluding endocrine disorders treatable with replacement therapy), or due to grade 2 myocarditis or recurrent grade 2 pneumonia.
b. Hypersensitivity to pembrolizumab and/or any of its excipients, grade 3 or higher.
c. History of an autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years.
However, hormone therapy (e.g., replacement therapy with thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary hypofunction) is not considered an exclusion criterion.
d. Diagnosed with immunodeficiency within 7 days prior to receiving the first dose of trial treatment, or currently receiving long-term systemic steroid therapy (daily dose exceeding 10 mg prednisone equivalent), or any other form of immunosuppressive therapy.
e. Received >30 Gy of radiation therapy to the lungs within 6 months prior to the first dose of trial treatment.
f. Have a history of (non-infectious) pneumonia/interstitial lung disease requiring steroid treatment, or currently have pneumonia/interstitial lung disease.
g. Have a history of allogeneic tissue or solid organ transplantation.
12. Received any live or attenuated vaccine within 4 weeks prior to the start of trial treatment. Attenuated vaccines are permitted.
13. Have an active infection requiring systemic treatment.
14. Patients who are seropositive for hepatitis B surface antigen (HBsAg) and have detectable hepatitis B virus (HBV) viral load are ineligible.
Note:
Patients who are HBsAg positive have received HBV antiviral therapy for at least 4 weeks and whose HBV viral load is undetectable before the start of trial treatment may be included in the trial.
• Patients should continue antiviral therapy throughout the trial and follow local HBV antiviral therapy guidelines after the trial.
15. Patients with a history of hepatitis C virus (HCV) infection and a detectable HCV viral load at screening are ineligible.
Note: Patients must have completed curative antiviral therapy at least 4 weeks prior to the start of the trial.
16. Within 6 months prior to starting the trial, patients must have any of the following medical histories: congestive heart failure of New York Heart Association class III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, hypertension uncontrolled with appropriate medication, current symptomatic arrhythmia > class 2, or any other serious heart disease (e.g., pericardial effusion or restrictive cardiomyopathy).
Patients with chronic atrial fibrillation who are receiving stable anticoagulation therapy are eligible.
17. Patients with any medical history, treatment history, abnormal laboratory test results, mental illness, social environmental factors, or other factors that may affect their ability to provide informed consent, the accuracy of trial results, or their ability to comply with trial requirements, to the point that the trial administrator determines that the patient's participation in the trial is not in their best interest.
18. Pregnant women or women who are breastfeeding.
1. Received systemic antitumor therapy or the investigational drug (whichever is shorter) within 28 days or 5 half-lives prior to the first dose of the investigational drug.
Note: Low-dose steroids (oral prednisone ≤ 10 mg daily or equivalent), hormone therapy for prostate or breast cancer (as adjuvant therapy), bisphosphonates, and RANKL inhibitors are all acceptable.
2. Received extensive radiation therapy ≤ 4 weeks prior to treatment initiation, or received palliative localized radiation therapy outside the chest or brain within ≤ 7 days prior to treatment initiation, or requires corticosteroid therapy due to radiation-related toxicity.
3. Patients diagnosed with a second malignant tumor within the past 3 years are ineligible for the trial, except in the following cases:
* Treated basal cell or localized squamous cell carcinoma of the skin
* Localized prostate cancer
* Cervical cancer in situ
* Resected colorectal adenomatous polyps
* Breast cancer in situ
* Other malignant tumors not currently receiving anti-tumor therapy.
Patients meeting these exceptions must be discussed with the trial commissioner before inclusion in the trial.
4. Patients with known active CNS metastases and/or carcinomatous meningitis.
5. Patients who have experienced a systemic arterial thrombotic or embolic event, such as a cerebrovascular accident (including ischemic attack) or hemoptysis, within 3 months prior to the first dose of the investigational drug.
6. Patients who have experienced a systemic venous thrombotic event (e.g., deep vein thrombosis) or a pulmonary artery event (e.g., pulmonary embolism) within 1 month prior to the first dose of the investigational drug. However, patients are eligible if they experienced a venous thrombotic event before receiving the first dose of the investigational drug and have been receiving stable anticoagulation therapy.
7. Left ventricular ejection ratio (LVEF) < 50%.
8. Major surgery within 4 weeks prior to the first dose of the investigational drug, and minor surgery within 2 weeks prior; all surgical wounds must have healed without infection or dehiscence. Patients must have fully recovered and have no ongoing surgical complications.
9. Significant proteinuria ≥ 2 g/24 hours, and/or nephrotic syndrome. If a patient's urine test strip shows 2+ or higher proteinuria, further evaluation, such as 24-hour urine collection, should be performed.
10. Known hypersensitivity or severe hypersensitivity to any component of the investigational drug, or, for patients receiving contrast agents, hypersensitivity to any component of the contrast agent.
11. For patients receiving pembrolizumab in combination:
a. Prior to any immunotherapy, treatment was discontinued due to a grade 3 or higher immune-related adverse event (excluding endocrine disorders treatable with replacement therapy), or due to grade 2 myocarditis or recurrent grade 2 pneumonia.
b. Hypersensitivity to pembrolizumab and/or any of its excipients, grade 3 or higher.
c. History of an autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years.
However, hormone therapy (e.g., replacement therapy with thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary hypofunction) is not considered an exclusion criterion.
d. Diagnosed with immunodeficiency within 7 days prior to receiving the first dose of trial treatment, or currently receiving long-term systemic steroid therapy (daily dose exceeding 10 mg prednisone equivalent), or any other form of immunosuppressive therapy.
e. Received >30 Gy of radiation therapy to the lungs within 6 months prior to the first dose of trial treatment.
f. Have a history of (non-infectious) pneumonia/interstitial lung disease requiring steroid treatment, or currently have pneumonia/interstitial lung disease.
g. Have a history of allogeneic tissue or solid organ transplantation.
12. Received any live or attenuated vaccine within 4 weeks prior to the start of trial treatment. Attenuated vaccines are permitted.
13. Have an active infection requiring systemic treatment.
14. Patients who are seropositive for hepatitis B surface antigen (HBsAg) and have detectable hepatitis B virus (HBV) viral load are ineligible.
Note:
Patients who are HBsAg positive have received HBV antiviral therapy for at least 4 weeks and whose HBV viral load is undetectable before the start of trial treatment may be included in the trial.
• Patients should continue antiviral therapy throughout the trial and follow local HBV antiviral therapy guidelines after the trial.
15. Patients with a history of hepatitis C virus (HCV) infection and a detectable HCV viral load at screening are ineligible.
Note: Patients must have completed curative antiviral therapy at least 4 weeks prior to the start of the trial.
16. Within 6 months prior to starting the trial, patients must have any of the following medical histories: congestive heart failure of New York Heart Association class III or IV, unstable angina, myocardial infarction, unstable symptomatic ischemic heart disease, hypertension uncontrolled with appropriate medication, current symptomatic arrhythmia > class 2, or any other serious heart disease (e.g., pericardial effusion or restrictive cardiomyopathy).
Patients with chronic atrial fibrillation who are receiving stable anticoagulation therapy are eligible.
17. Patients with any medical history, treatment history, abnormal laboratory test results, mental illness, social environmental factors, or other factors that may affect their ability to provide informed consent, the accuracy of trial results, or their ability to comply with trial requirements, to the point that the trial administrator determines that the patient's participation in the trial is not in their best interest.
18. Pregnant women or women who are breastfeeding.
The Estimated Number of Participants
-
Taiwan
25 participants
-
Global
257 participants
