Clinical Trials List
Protocol NumberHMBD-001-103
Active
2024-10-25 - 2026-12-31
Phase I
Recruiting4
A Phase 1b Study to Evaluate HMBD-001 in Combination with Docetaxel with or without Cetuximab in Participants with Advanced Squamous Non-Small Cell Lung Cancers, and HMBD-001 in Combination with Cetuximab in Participants with Advanced Squamous Cell Cancers
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Trial Applicant
IQVIA RDS Taiwan Ltd.
-
Sponsor
Hummingbird Bioscience Australia Pty Ltd
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/12/01
Investigators and Locations
Co-Principal Investigator
- 郭家佑 Division of Thoracic Medicine
- 莊政皓 Division of Thoracic Medicine
- Inn-Wen Chong Division of Thoracic Medicine
- Chih-Jen Yang Division of Thoracic Medicine
- 李玫萱 Division of Thoracic Medicine
- Ying-Ming Tsai Tsai Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 鍾秉軒 Division of Hematology & Oncology
- 黃怡璇 Division of Hematology & Oncology
- 黃怡菁 Division of Hematology & Oncology
- 劉奕廷 Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
- Seu-Chun Yang Division of General Internal Medicine
- Wu-Chou Su Division of Hematology & Oncology
- Chien-Chung Lin Division of General Internal Medicine
- Yu-Min Yeh Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- YEN-HAN TSENG Division of Thoracic Medicine
- Hsu-ching Huang Division of Thoracic Medicine
- Chi-Lu Chiang Division of Thoracic Medicine
- Yung-Hung Luo Division of Hematology & Oncology
- 廖映庭 Division of Thoracic Medicine
- 趙恒勝 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Wei-Hong Cheng
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Cetuximab in Participants with Advanced Squamous Cell Cancers
Objectives
To assess the safety and tolerability of HMBD001 in combination with docetaxel in participants
with advanced squamous non-small cell lung
cancer (sqNSCLC)
Test Drug
injective
Active Ingredient
CETUXIMAB, CHIMERIC ANTIBODY
HMBD-001
DOCETAXEL
DOCETAXEL ANHYDROUS
HMBD-001
DOCETAXEL
DOCETAXEL ANHYDROUS
Dosage Form
27D
27D
270
279
27D
270
279
Dosage
500mg/100mL
500mg/10mL
20mg/1ml及80mg/4ml
1ml 及 80mg / 4ml
500mg/10mL
20mg/1ml及80mg/4ml
1ml 及 80mg / 4ml
Endpoints
Group B: Evaluate the safety and tolerability of HMBD-001 in combination with docetaxel and cetuximab in participants with advanced sqNSCLC.
Assess the preliminary antitumor activity of HMBD-001 in combination with docetaxel and cetuximab based on the objective response rate (ORR) in participants with advanced sqNSCLC.
Group C: Evaluate the safety and tolerability of HMBD-001 in combination with cetuximab in participants with advanced squamous cell carcinoma.
Assess the preliminary antitumor activity of HMBD-001 in combination with docetaxel and cetuximab based on the objective response rate (ORR) in participants with advanced sqNSCLC.
Group C: Evaluate the safety and tolerability of HMBD-001 in combination with cetuximab in participants with advanced squamous cell carcinoma.
Inclution Criteria
To be eligible to participate in the trial, each participant must meet all of the following inclusion criteria:
1. Willing and able to provide subject consent before commencing any trial procedures and assessments, and must be willing to comply with all trial procedures.
2. Adult participant aged 18 years or older (or of legal age under local laws, if the legal age is >18 years).
3. ECOG (Eastern Cooperative Oncology Group) fitness level of 0-1.
4. For Group A participants (recruitment has ceased since Trial Proposal V 3.0):
• Histological or cytological evidence of locally advanced unresectable or metastatic sqNSCLC;
• Disease must have worsened during at least one approved or similar platinum-based therapy for sqNSCLC;
• Participants must have previously received anti-programmed cell death protein 1 (PD1) or anti-programmed cell death ligand 1 (PDL1) therapy;
• Participants must not have previously received >2 lines of systemic therapy for advanced disease. Adjuvant or pre-adjuvant therapy received within 6 months of the recommended cycle 1 day 1 (C1D1) will be counted as first-line therapy.
• Participants who refuse or are deemed unsuitable for standard care may be approved on a case-by-case basis after discussion with the trial commissioner if it is determined that the risk of adverse cancer outcomes or treatment-related toxicities and/or impact on the integrity of trial results is unlikely to increase.
For participants in Group B (HMBD-001 with docetaxel and cetuximab):
• Histological or cytological evidence of locally advanced unresectable or metastatic sqNSCLC;
• Disease must have progressed during at least one approved or similar platinum-based therapy for sqNSCLC;
• Participants must have previously received anti-PD1 or anti-PDL1 therapy. This condition does not apply to participants from countries where anti-PD1 or anti-PDL1 therapy is not approved or applicable as standard care;
• Participants must not have previously received >2 lines of systemic therapy for advanced disease. Adjuvant or pre-adjuvant therapies received within 6 months of the recommended Day 1 of Cycle 1 (C1D1) will be counted as first-line treatment;
• Participants who refuse or are deemed unsuitable for standard care may be approved on a case-by-case basis after discussion with the trial commissioner if it is determined that the risk of adverse cancer outcomes or treatment-related toxicities and/or impact on the integrity of trial results is unlikely to increase.
For participants in Group C (HMBD-001 with cetuximab):
• Histological or cytological evidence of locally advanced unresectable or metastatic sqNSCLC, head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), cutaneous squamous cell carcinoma (CSCC), or cervical SCC; participants with other primary sites of SCC may be permitted, subject to approval by the trial commissioner;
• Participants must have previously received at least one line of systemic therapy for advanced disease and, in metastatic cases, no more than three lines of therapy. (Note: Subject to approval by the trial sponsor, participants with a history of >3 lines of prior therapy in metastatic conditions may be permitted, depending on the specific circumstances);
• Adjuvant or pre-adjuvant therapy received within 6 months of the recommended Day 1 of Cycle 1 (C1D1) will be counted as first-line therapy;
• Participants who refuse or are deemed unsuitable for standard care may be permitted, subject to discussion with the trial sponsor, if it is deemed unlikely that the participant will face an increased risk of adverse cancer outcomes or treatment-related toxicities and/or affect the integrity of the trial results.
6. The participant's life expectancy must be >3 months, as determined by the trial principal investigator.
7. Participants must have a measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1. Note: Previously irradiated tumor lesions are considered measurable if the lesion has progressed after radiation therapy.
8. Participants must be willing to provide fresh tumor slides (formalin-fixed, paraffin-embedded, FFPE) specimens. Participants without any fresh slide specimens may be approved for inclusion on a case-by-case basis after discussion with the trial commissioner if available stock tissue (at least 15 consecutive, unstained FFPE slides or 1 FFPE tissue block). Participants without any stock tissue or fresh slide specimens, or who refuse to provide stock tissue, may be approved for inclusion on a case-by-case basis after discussion with the trial commissioner.
9. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test within 72 hours prior to the first dose of the investigational drug and must not be breastfeeding.
10. WOCBP is defined as women who have not undergone surgical sterilization or are postmenopausal. If a female participant has not menstruated for 12 months without other medical reasons, she will be considered postmenopausal. For female participants under 50 years of age who meet the criteria for postmenopausal status and have not undergone sterilization, further testing of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels should be considered to confirm serological postmenopausal status.
11. WOCBP participants must agree to use highly effective contraception during the trial and for 90 days after the last dose of trial treatment. Acceptable contraceptive methods are described in Section VIII.
12. Male participants of fertility must avoid impregnating their partners and use highly effective contraception during the trial and for 90 days after the last dose of trial treatment. All male participants must agree not to donate sperm during the trial and for 90 days after the last dose of trial treatment. Acceptable contraceptive methods are described in Section VIII.
13. Adequate baseline organ function, as shown below:
a. Creatinine clearance (CrCl) ≥ 45 c.c./min, calculated according to the Cockcroft-Gault formula:
i. CrCl (male) = ([140 - age] × weight (kg)) / (serum creatinine × 72)
ii. CrCl (female) = CrCl (male) × 0.85
b. Serum albumin ≥ 2.5 g/dL.
c. Total bilirubin (TBL) ≤ 1.5 times the institutional upper limit of normal (ULN). For participants with confirmed/suspected Gilbert’s disease, TBL < 3 times ULN.
d. AST and ALT ≤ 2.5 times the institutional ULN. If a participant has liver metastases, their alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels may be < 5 times the institutional ULN.
14. Participants not taking warfarin or other oral anticoagulants: International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 times the ULN; and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times the ULN. Participants taking warfarin should use a stable dose to achieve a stable INR < 3.5. In participants receiving other oral anticoagulant therapy, PT or aPTT must be within the expected therapeutic range of the anticoagulant.
15. Adequate baseline hematological function, as shown below:
a. Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L.
b. Hemoglobin ≥9 g/dL, and no red blood cell (RBC) transfusions in the preceding 14 days.
16. Platelet count ≥100 × 10⁹/L, and no platelet transfusions in the preceding 14 days.
Note: Inclusion criterion 5 was removed in the first revision of the trial protocol (version 2.0).
1. Willing and able to provide subject consent before commencing any trial procedures and assessments, and must be willing to comply with all trial procedures.
2. Adult participant aged 18 years or older (or of legal age under local laws, if the legal age is >18 years).
3. ECOG (Eastern Cooperative Oncology Group) fitness level of 0-1.
4. For Group A participants (recruitment has ceased since Trial Proposal V 3.0):
• Histological or cytological evidence of locally advanced unresectable or metastatic sqNSCLC;
• Disease must have worsened during at least one approved or similar platinum-based therapy for sqNSCLC;
• Participants must have previously received anti-programmed cell death protein 1 (PD1) or anti-programmed cell death ligand 1 (PDL1) therapy;
• Participants must not have previously received >2 lines of systemic therapy for advanced disease. Adjuvant or pre-adjuvant therapy received within 6 months of the recommended cycle 1 day 1 (C1D1) will be counted as first-line therapy.
• Participants who refuse or are deemed unsuitable for standard care may be approved on a case-by-case basis after discussion with the trial commissioner if it is determined that the risk of adverse cancer outcomes or treatment-related toxicities and/or impact on the integrity of trial results is unlikely to increase.
For participants in Group B (HMBD-001 with docetaxel and cetuximab):
• Histological or cytological evidence of locally advanced unresectable or metastatic sqNSCLC;
• Disease must have progressed during at least one approved or similar platinum-based therapy for sqNSCLC;
• Participants must have previously received anti-PD1 or anti-PDL1 therapy. This condition does not apply to participants from countries where anti-PD1 or anti-PDL1 therapy is not approved or applicable as standard care;
• Participants must not have previously received >2 lines of systemic therapy for advanced disease. Adjuvant or pre-adjuvant therapies received within 6 months of the recommended Day 1 of Cycle 1 (C1D1) will be counted as first-line treatment;
• Participants who refuse or are deemed unsuitable for standard care may be approved on a case-by-case basis after discussion with the trial commissioner if it is determined that the risk of adverse cancer outcomes or treatment-related toxicities and/or impact on the integrity of trial results is unlikely to increase.
For participants in Group C (HMBD-001 with cetuximab):
• Histological or cytological evidence of locally advanced unresectable or metastatic sqNSCLC, head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), cutaneous squamous cell carcinoma (CSCC), or cervical SCC; participants with other primary sites of SCC may be permitted, subject to approval by the trial commissioner;
• Participants must have previously received at least one line of systemic therapy for advanced disease and, in metastatic cases, no more than three lines of therapy. (Note: Subject to approval by the trial sponsor, participants with a history of >3 lines of prior therapy in metastatic conditions may be permitted, depending on the specific circumstances);
• Adjuvant or pre-adjuvant therapy received within 6 months of the recommended Day 1 of Cycle 1 (C1D1) will be counted as first-line therapy;
• Participants who refuse or are deemed unsuitable for standard care may be permitted, subject to discussion with the trial sponsor, if it is deemed unlikely that the participant will face an increased risk of adverse cancer outcomes or treatment-related toxicities and/or affect the integrity of the trial results.
6. The participant's life expectancy must be >3 months, as determined by the trial principal investigator.
7. Participants must have a measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) V1.1. Note: Previously irradiated tumor lesions are considered measurable if the lesion has progressed after radiation therapy.
8. Participants must be willing to provide fresh tumor slides (formalin-fixed, paraffin-embedded, FFPE) specimens. Participants without any fresh slide specimens may be approved for inclusion on a case-by-case basis after discussion with the trial commissioner if available stock tissue (at least 15 consecutive, unstained FFPE slides or 1 FFPE tissue block). Participants without any stock tissue or fresh slide specimens, or who refuse to provide stock tissue, may be approved for inclusion on a case-by-case basis after discussion with the trial commissioner.
9. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test within 72 hours prior to the first dose of the investigational drug and must not be breastfeeding.
10. WOCBP is defined as women who have not undergone surgical sterilization or are postmenopausal. If a female participant has not menstruated for 12 months without other medical reasons, she will be considered postmenopausal. For female participants under 50 years of age who meet the criteria for postmenopausal status and have not undergone sterilization, further testing of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels should be considered to confirm serological postmenopausal status.
11. WOCBP participants must agree to use highly effective contraception during the trial and for 90 days after the last dose of trial treatment. Acceptable contraceptive methods are described in Section VIII.
12. Male participants of fertility must avoid impregnating their partners and use highly effective contraception during the trial and for 90 days after the last dose of trial treatment. All male participants must agree not to donate sperm during the trial and for 90 days after the last dose of trial treatment. Acceptable contraceptive methods are described in Section VIII.
13. Adequate baseline organ function, as shown below:
a. Creatinine clearance (CrCl) ≥ 45 c.c./min, calculated according to the Cockcroft-Gault formula:
i. CrCl (male) = ([140 - age] × weight (kg)) / (serum creatinine × 72)
ii. CrCl (female) = CrCl (male) × 0.85
b. Serum albumin ≥ 2.5 g/dL.
c. Total bilirubin (TBL) ≤ 1.5 times the institutional upper limit of normal (ULN). For participants with confirmed/suspected Gilbert’s disease, TBL < 3 times ULN.
d. AST and ALT ≤ 2.5 times the institutional ULN. If a participant has liver metastases, their alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels may be < 5 times the institutional ULN.
14. Participants not taking warfarin or other oral anticoagulants: International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 times the ULN; and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 times the ULN. Participants taking warfarin should use a stable dose to achieve a stable INR < 3.5. In participants receiving other oral anticoagulant therapy, PT or aPTT must be within the expected therapeutic range of the anticoagulant.
15. Adequate baseline hematological function, as shown below:
a. Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L.
b. Hemoglobin ≥9 g/dL, and no red blood cell (RBC) transfusions in the preceding 14 days.
16. Platelet count ≥100 × 10⁹/L, and no platelet transfusions in the preceding 14 days.
Note: Inclusion criterion 5 was removed in the first revision of the trial protocol (version 2.0).
Exclusion Criteria
Participants meeting any of the following exclusion criteria must be excluded from this trial:
1. Prior treatment with HMBD-001, docetaxel, cetuximab, or any other drug targeting the epidermal growth factor receptor (EGFR) or HER3 (human epidermal growth factor receptor 3) (including pan-HER inhibitors). Participants in Group C are permitted to have prior docetaxel treatment. For example, for Group C HNSCC patients who have previously received cetuximab as part of radical chemoradiotherapy, inclusion may be approved on a case-by-case basis after discussion with the trial commissioner.
2. Prior targeted therapy, including but not limited to treatment for EGFR activating mutations, ALK fusions, ROS (proto-oncogene tyrosine-protein kinase) rearrangements, RET (rearranged during transfection) fusions or mutations, BRAF V600E mutations, MET (mesenchymal-epithelial transition factor) exon 14 skipped-read mutations, and/or KRAS G12C mutations. Exemption from prior targeted therapy may be discussed with the trial commissioner, provided that such treatment is deemed unlikely to affect the efficacy of the treatment regimen and/or impose a high risk of toxicity on the participant.
3. The participant has received anticancer therapy, including cytotoxic chemotherapy, monoclonal antibodies, small molecule tyrosine kinase inhibitors, and/or investigational systemic anticancer agents, within 28 days prior to administration of the investigational treatment (42 days prior to prior use of nitrosourea or mitomycin C) or within 5 half-lives (whichever is shorter).
4. The participant has received radiation therapy or major surgery within 4 weeks prior to the first dose of the investigational drug. If it is determined that this will not increase the participant's risk of adverse drug effects and/or interfere with the integrity of the trial results, approval may be granted on a case-by-case basis, after discussion with the trial commissioner, for localized radiation therapy or minor surgery to alleviate disease within 4 weeks of receiving the first dose of the investigational drug.
5. Participants with brain metastases, unless they meet all of the following criteria:
• They are clinically and radiologically stable for at least 28 days prior to receiving the first dose of the investigational drug (no evidence of worsening on imaging; the same imaging modality (Magnetic Resonance Imaging, MRI or computed tomography, CT) must be used for each evaluation); and
• Any neurological symptoms have returned to baseline levels.
• Note: Participants with a history of leptomeningeal disease may be excluded even if clinically stable.
6. Any other known active malignancy, except for treated cervical intraepithelial neoplasia or non-melanoma skin cancer. Participants with a history of low-probability recurrence malignancy who have received radical treatment may be approved on a case-by-case basis after discussion with the trial commissioner, provided it is determined that this will not increase the risk of adverse drug effects and/or interfere with the integrity of the trial results.
7. Participants with a history of low-probability recurrence malignancy who have received radical treatment and have a history of HMBD-001 or any of its excipients, docetaxel, and/or cetuximab. 8. History of uncontrollable allergic reactions and/or a history of known or anticipated allergic reactions (related to the participant's enrollment cohort).
9. History of severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or acute generalized exanthematous pustulosis (AGEP).
10. Currently participating in any other investigational trial.
11. Left ventricular ejection fraction < 50%.
12. Clinically significant cardiovascular disease (e.g., uncontrollable or any New York Heart Association grade 3 or 4 heart failure, uncontrollable angina, 6 pre-trial complications). 11. History of myocardial infarction, unstable angina or stroke, uncontrolled hypertension or clinically significant arrhythmia uncontrolled by medication within the past month.
12. History of macular edema, keratitis, ulcerative keratitis or severe dry eye.
13. History of interstitial lung disease or clinically significant and symptomatic lung disease, such as chronic obstructive pulmonary disease or pulmonary hypertension.
14. Uncontrollable major clinical medical problems or uncontrollable comorbidities, including but not limited to uncontrollable infections requiring systemic treatment, disseminated intravascular coagulation, or mental illness/social circumstances that would limit compliance with trial requirements.
15. Persistent and clinically significant toxicity (> Grade 2) caused by previous anticancer treatment (Grade 2 chemotherapy-related neuropathy and alopecia are not included and are therefore permissible). Previously caused toxicities leading to abnormal laboratory test results should have resolved to ≤ Grade 1. Grade 10, unless inclusion criteria allow for a higher grade of abnormality. If laboratory test results are abnormal and require medical treatment, the dosage and laboratory values should be stable.
16. Treatment with a potent CYP3A4 (cytochrome P450 3A4) inhibitor or inducer. If the participant is receiving such treatment, a non-CYP3A4 receptor may be used as an alternative prior to trial treatment.
17. QTc (corrected QT) interval > 450 ms (male) or > 470 ms (female).
18. Positive for human immunodeficiency virus (HIV).
19. Active or chronic hepatitis B or C.
20. Any medical condition deemed by the trial administrator to place the participant at an unacceptably high risk of toxicity.
21. Infection with severe special infectious pneumonia (COVID-19) within 3 months prior to C1D1.
22. COVID-19 vaccination within 14 days of C1D1. Vaccines.
23. Any uncontrollable comorbidity or clinically significant uncontrollable condition, including but not limited to live bacterial, fungal, or viral infections requiring systemic treatment.
1. Prior treatment with HMBD-001, docetaxel, cetuximab, or any other drug targeting the epidermal growth factor receptor (EGFR) or HER3 (human epidermal growth factor receptor 3) (including pan-HER inhibitors). Participants in Group C are permitted to have prior docetaxel treatment. For example, for Group C HNSCC patients who have previously received cetuximab as part of radical chemoradiotherapy, inclusion may be approved on a case-by-case basis after discussion with the trial commissioner.
2. Prior targeted therapy, including but not limited to treatment for EGFR activating mutations, ALK fusions, ROS (proto-oncogene tyrosine-protein kinase) rearrangements, RET (rearranged during transfection) fusions or mutations, BRAF V600E mutations, MET (mesenchymal-epithelial transition factor) exon 14 skipped-read mutations, and/or KRAS G12C mutations. Exemption from prior targeted therapy may be discussed with the trial commissioner, provided that such treatment is deemed unlikely to affect the efficacy of the treatment regimen and/or impose a high risk of toxicity on the participant.
3. The participant has received anticancer therapy, including cytotoxic chemotherapy, monoclonal antibodies, small molecule tyrosine kinase inhibitors, and/or investigational systemic anticancer agents, within 28 days prior to administration of the investigational treatment (42 days prior to prior use of nitrosourea or mitomycin C) or within 5 half-lives (whichever is shorter).
4. The participant has received radiation therapy or major surgery within 4 weeks prior to the first dose of the investigational drug. If it is determined that this will not increase the participant's risk of adverse drug effects and/or interfere with the integrity of the trial results, approval may be granted on a case-by-case basis, after discussion with the trial commissioner, for localized radiation therapy or minor surgery to alleviate disease within 4 weeks of receiving the first dose of the investigational drug.
5. Participants with brain metastases, unless they meet all of the following criteria:
• They are clinically and radiologically stable for at least 28 days prior to receiving the first dose of the investigational drug (no evidence of worsening on imaging; the same imaging modality (Magnetic Resonance Imaging, MRI or computed tomography, CT) must be used for each evaluation); and
• Any neurological symptoms have returned to baseline levels.
• Note: Participants with a history of leptomeningeal disease may be excluded even if clinically stable.
6. Any other known active malignancy, except for treated cervical intraepithelial neoplasia or non-melanoma skin cancer. Participants with a history of low-probability recurrence malignancy who have received radical treatment may be approved on a case-by-case basis after discussion with the trial commissioner, provided it is determined that this will not increase the risk of adverse drug effects and/or interfere with the integrity of the trial results.
7. Participants with a history of low-probability recurrence malignancy who have received radical treatment and have a history of HMBD-001 or any of its excipients, docetaxel, and/or cetuximab. 8. History of uncontrollable allergic reactions and/or a history of known or anticipated allergic reactions (related to the participant's enrollment cohort).
9. History of severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), or acute generalized exanthematous pustulosis (AGEP).
10. Currently participating in any other investigational trial.
11. Left ventricular ejection fraction < 50%.
12. Clinically significant cardiovascular disease (e.g., uncontrollable or any New York Heart Association grade 3 or 4 heart failure, uncontrollable angina, 6 pre-trial complications). 11. History of myocardial infarction, unstable angina or stroke, uncontrolled hypertension or clinically significant arrhythmia uncontrolled by medication within the past month.
12. History of macular edema, keratitis, ulcerative keratitis or severe dry eye.
13. History of interstitial lung disease or clinically significant and symptomatic lung disease, such as chronic obstructive pulmonary disease or pulmonary hypertension.
14. Uncontrollable major clinical medical problems or uncontrollable comorbidities, including but not limited to uncontrollable infections requiring systemic treatment, disseminated intravascular coagulation, or mental illness/social circumstances that would limit compliance with trial requirements.
15. Persistent and clinically significant toxicity (> Grade 2) caused by previous anticancer treatment (Grade 2 chemotherapy-related neuropathy and alopecia are not included and are therefore permissible). Previously caused toxicities leading to abnormal laboratory test results should have resolved to ≤ Grade 1. Grade 10, unless inclusion criteria allow for a higher grade of abnormality. If laboratory test results are abnormal and require medical treatment, the dosage and laboratory values should be stable.
16. Treatment with a potent CYP3A4 (cytochrome P450 3A4) inhibitor or inducer. If the participant is receiving such treatment, a non-CYP3A4 receptor may be used as an alternative prior to trial treatment.
17. QTc (corrected QT) interval > 450 ms (male) or > 470 ms (female).
18. Positive for human immunodeficiency virus (HIV).
19. Active or chronic hepatitis B or C.
20. Any medical condition deemed by the trial administrator to place the participant at an unacceptably high risk of toxicity.
21. Infection with severe special infectious pneumonia (COVID-19) within 3 months prior to C1D1.
22. COVID-19 vaccination within 14 days of C1D1. Vaccines.
23. Any uncontrollable comorbidity or clinically significant uncontrollable condition, including but not limited to live bacterial, fungal, or viral infections requiring systemic treatment.
The Estimated Number of Participants
-
Taiwan
7 participants
-
Global
98 participants
