Clinical Trials List
Protocol NumberLBL-001
Active
2024-03-01 - 2026-12-31
Phase I
Recruiting3
A Phase I, Open-label, Dose-finding Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LBL-01 Injection in Patients with Advanced Solid Tumors
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Trial Applicant
QPS
-
Sponsor
-
Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chien-Jui Huang Division of General Internal Medicine
- Chia-Jui Yen Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 呂理駿 Division of Hematology & Oncology
- Kun-Huei Yeh Division of Hematology & Oncology
- 陳柏邑 Division of Hematology & Oncology
- WEI-LI MA Division of Hematology & Oncology
- Hsiang-Fong Kao Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Ming-Shun Wu
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumors
Objectives
1. To determine the maximum tolerated dose (MTD)
2. To assess the safety and tolerability of LBL-01 Injection
Test Drug
injective
Active Ingredient
LBL-01
Dosage Form
270
Dosage
20 mg/mL
Endpoints
Frequency of dose-limiting toxicities (DLTs)
2. Frequency, type, and severity of adverse events (AEs) graded according to the
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAEs)
2. Frequency, type, and severity of adverse events (AEs) graded according to the
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
(CTCAEs)
Inclution Criteria
1. Sign the participant consent form.
2. Be 18 years of age or older.
3. Be a patient with histologically or cytologically confirmed advanced malignant tumors who have not responded to standard treatment, have no available standard treatment, are unsuitable for, or cannot tolerate all standard treatments.
4. Have measurable or evaluable solid tumor lesions according to the RECIST v1.1 criteria.
5. Have an ECOG Performance Status score of 0 or 1.
6. Meet the following criteria for hematopoietic and hepatic/renal function indices:
a. Absolute neutrophil count (ANC) ≥ 1500/μL
b. Platelet count ≥ 75,000/μL
c. Hemoglobin ≥ 8 g/dL
d. Total bilirubin < 1.5 times the upper limit of the standard value. Patients with Gilbert's syndrome: Less than or equal to 3 times the upper limit of the standard value.
e. For non-liver metastatic patients, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels are less than or equal to 3 times the upper limit of the standard value; for liver metastatic patients, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels are less than or equal to 5 times the upper limit of the standard value.
f. Estimated glomerular filtration rate (GFR) is greater than or equal to 50 mL/min/1.73 m^2.
Blood transfusion is not permitted to meet the inclusion criteria. 1. Signed participant consent form.
2. 18 years of age or older.
3. Patients with histologically or cytologically confirmed advanced malignant tumors who have not responded to standard treatment, have no standard treatment available, are unsuitable for, or cannot tolerate all standard treatments.
4. Measurable or evaluable solid tumor lesions are present according to the Responsive Evaluation Criteria in Solid Tumors (RECIST v1.1).
5. ECOG Performance Status is 0 or 1.
6. Hematopoietic and hepatic/renal function indices meet the following criteria:
a. Absolute neutrophil count (ANC) ≥ 1500/μL
b. Platelet count ≥ 75,000/μL
c. Hemoglobin ≥ 8 g/dL
d. Total bilirubin < 1.5 times the upper limit of the standard value. For patients with Gilbert's syndrome: < 3 times the upper limit of the standard value.
e. In non-liver metastatic patients, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels are less than or equal to three times the upper limit of the standard value; in liver metastatic patients, AST or ALT levels are less than or equal to five times the upper limit of the standard value.
f. Estimated glomerular filtration rate (GFR) is greater than or equal to 60 mL/min/1.73 m^2.
Blood transfusion is not permitted to meet the inclusion criteria.
2. Be 18 years of age or older.
3. Be a patient with histologically or cytologically confirmed advanced malignant tumors who have not responded to standard treatment, have no available standard treatment, are unsuitable for, or cannot tolerate all standard treatments.
4. Have measurable or evaluable solid tumor lesions according to the RECIST v1.1 criteria.
5. Have an ECOG Performance Status score of 0 or 1.
6. Meet the following criteria for hematopoietic and hepatic/renal function indices:
a. Absolute neutrophil count (ANC) ≥ 1500/μL
b. Platelet count ≥ 75,000/μL
c. Hemoglobin ≥ 8 g/dL
d. Total bilirubin < 1.5 times the upper limit of the standard value. Patients with Gilbert's syndrome: Less than or equal to 3 times the upper limit of the standard value.
e. For non-liver metastatic patients, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels are less than or equal to 3 times the upper limit of the standard value; for liver metastatic patients, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels are less than or equal to 5 times the upper limit of the standard value.
f. Estimated glomerular filtration rate (GFR) is greater than or equal to 50 mL/min/1.73 m^2.
Blood transfusion is not permitted to meet the inclusion criteria. 1. Signed participant consent form.
2. 18 years of age or older.
3. Patients with histologically or cytologically confirmed advanced malignant tumors who have not responded to standard treatment, have no standard treatment available, are unsuitable for, or cannot tolerate all standard treatments.
4. Measurable or evaluable solid tumor lesions are present according to the Responsive Evaluation Criteria in Solid Tumors (RECIST v1.1).
5. ECOG Performance Status is 0 or 1.
6. Hematopoietic and hepatic/renal function indices meet the following criteria:
a. Absolute neutrophil count (ANC) ≥ 1500/μL
b. Platelet count ≥ 75,000/μL
c. Hemoglobin ≥ 8 g/dL
d. Total bilirubin < 1.5 times the upper limit of the standard value. For patients with Gilbert's syndrome: < 3 times the upper limit of the standard value.
e. In non-liver metastatic patients, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels are less than or equal to three times the upper limit of the standard value; in liver metastatic patients, AST or ALT levels are less than or equal to five times the upper limit of the standard value.
f. Estimated glomerular filtration rate (GFR) is greater than or equal to 60 mL/min/1.73 m^2.
Blood transfusion is not permitted to meet the inclusion criteria.
Exclusion Criteria
Participants will be ineligible to participate in this trial if they have any of the following conditions:
1. Received treatment with an approved or trial-tested anticancer drug within 28 days prior to the first dose of the investigational drug or within five half-lives of the drug (whichever is shorter).
2. Received eradicative radiation therapy within 28 days prior to the first dose of the investigational drug or palliative radiation therapy within 7 days prior to the first dose.
3. Received any vaccine within 30 days prior to the first dose of the investigational drug.
4. Received an immunomodulatory agent or immunosuppressant (greater than or equal to 10 mg prednisone daily or an equivalent dose).
5. Moderate or severe primary immunodeficiency (e.g., DeGeorge syndrome or Wescott-Aldrich II syndrome).
6. Have clinically significant conditions, including unstable angina or congestive heart failure (New York Heart Association functional class 3 or 4).
7. An acute myocardial infarction or cerebrovascular accident occurred within 6 months prior to receiving the first dose of the investigational drug.
8. A history of primary or metastatic central nervous system tumors, but whose condition is stable or asymptomatic after treatment, is not included in this restriction.
9. Toxicity resulting from previous treatment or surgery has not recovered to a severity level less than or equal to NCI CTCAE v5.0 grade 1, except for hair loss and hyperpigmentation or hypopigmentation.
10. Opportunistic infection with acquired immunodeficiency syndrome (AIDS) within the past 12 months.
11. Uncontrollable hypertension: i.e., systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg after optimal drug therapy.
12. Positive results for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (anti-HCV); subjects with positive anti-HCV antibody (anti-HCV Ab) must have HCV RNA levels below the detection limit to be included in the trial. If a subject is HBsAg positive or has detectable HCV RNA during screening, they can be included in the trial only if they have received antiviral treatment according to local medical guidelines prior to enrollment.
13. Acute infectious disease or active pulmonary tuberculosis.
14. QTcF greater than 480 milliseconds (msec).
15. Underwent major surgery or suffered major trauma (as determined by the trial physician) within 28 days prior to receiving the first dose of the investigational drug, and currently has complications arising from the surgery.
16. Individuals who have experienced or are suspected of experiencing allergic reactions to the contents of LBL-01 injection (histidine, sucrose, polysorbate 80).
17. Pregnant or breastfeeding women.
18. Individuals who are men of reproductive potential but do not agree to use effective contraception during the trial, or women of reproductive potential but do not agree to use effective contraception during the trial and for four months after receiving the last dose of the investigational drug. Effective contraception includes implants, injections, combined oral contraceptives, IUDs, abstinence, surgical contraception, or sterilized partners.
19. Individuals whose pre-existing medical conditions or current health status, as assessed by the investigating physician, may have their participation in this trial affected by its impact on their safety, prevent them from meeting the trial requirements, or affect the assessment of trial results.
1. Received treatment with an approved or trial-tested anticancer drug within 28 days prior to the first dose of the investigational drug or within five half-lives of the drug (whichever is shorter).
2. Received eradicative radiation therapy within 28 days prior to the first dose of the investigational drug or palliative radiation therapy within 7 days prior to the first dose.
3. Received any vaccine within 30 days prior to the first dose of the investigational drug.
4. Received an immunomodulatory agent or immunosuppressant (greater than or equal to 10 mg prednisone daily or an equivalent dose).
5. Moderate or severe primary immunodeficiency (e.g., DeGeorge syndrome or Wescott-Aldrich II syndrome).
6. Have clinically significant conditions, including unstable angina or congestive heart failure (New York Heart Association functional class 3 or 4).
7. An acute myocardial infarction or cerebrovascular accident occurred within 6 months prior to receiving the first dose of the investigational drug.
8. A history of primary or metastatic central nervous system tumors, but whose condition is stable or asymptomatic after treatment, is not included in this restriction.
9. Toxicity resulting from previous treatment or surgery has not recovered to a severity level less than or equal to NCI CTCAE v5.0 grade 1, except for hair loss and hyperpigmentation or hypopigmentation.
10. Opportunistic infection with acquired immunodeficiency syndrome (AIDS) within the past 12 months.
11. Uncontrollable hypertension: i.e., systolic blood pressure greater than 160 mmHg and/or diastolic blood pressure greater than 100 mmHg after optimal drug therapy.
12. Positive results for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (anti-HCV); subjects with positive anti-HCV antibody (anti-HCV Ab) must have HCV RNA levels below the detection limit to be included in the trial. If a subject is HBsAg positive or has detectable HCV RNA during screening, they can be included in the trial only if they have received antiviral treatment according to local medical guidelines prior to enrollment.
13. Acute infectious disease or active pulmonary tuberculosis.
14. QTcF greater than 480 milliseconds (msec).
15. Underwent major surgery or suffered major trauma (as determined by the trial physician) within 28 days prior to receiving the first dose of the investigational drug, and currently has complications arising from the surgery.
16. Individuals who have experienced or are suspected of experiencing allergic reactions to the contents of LBL-01 injection (histidine, sucrose, polysorbate 80).
17. Pregnant or breastfeeding women.
18. Individuals who are men of reproductive potential but do not agree to use effective contraception during the trial, or women of reproductive potential but do not agree to use effective contraception during the trial and for four months after receiving the last dose of the investigational drug. Effective contraception includes implants, injections, combined oral contraceptives, IUDs, abstinence, surgical contraception, or sterilized partners.
19. Individuals whose pre-existing medical conditions or current health status, as assessed by the investigating physician, may have their participation in this trial affected by its impact on their safety, prevent them from meeting the trial requirements, or affect the assessment of trial results.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
30 participants
