Clinical Trials List
Protocol NumberBGB-A317-A445-101
NCT Number(ClinicalTrials.gov Identfier)NCT04215978
Completed
2022-09-01 - 2024-12-20
Phase I
Recruiting4
ICD-10C00.0
Malignant neoplasm of external upper lip
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9140.0
Malignant neoplasm of upper lip, vermilion border
Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of the Anti OX40 Agonist Monoclonal Antibody BGB-A445 in Combination With the Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 何宇傑 Division of Radiation Therapy
- 謝明妤 Division of Otolaryngology
- 曾若涵 Division of Hematology & Oncology
- 林聖皓 Division of Thoracic Medicine
- 李尚儀 Division of Otolaryngology
- 林俊雄 Division of Thoracic Medicine
- 楊繕駿 Division of Radiation Therapy
- 林俊維 無
- 林炫聿 Division of Hematology & Oncology
- 林慶雄 Division of Thoracic Medicine
- 余萬年 Division of Otolaryngology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 劉奕廷
- 顏志傑
- Shang-Yin Wu
- Chien-Jui Huang Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Advanced Solid Tumor、 Non Small Cell Lung Cancer 、Head and Neck Squamous Cell Carcinoma (HNSCC) 、Nasopharyngeal Carcinoma (NPC)
Objectives
Phase 1a (dose escalation) Primary Objectives:
‧ To evaluate the safety and tolerability of BGB-A445 monotherapy and BGB-A445 combined with tislelizumab in patients with advanced solid tumors
‧ Determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of BGB-A445 monotherapy and BGB-A445 plus tislelizumab
Phase 1b (dose expansion) Primary objective: Determine the RP2D of BGB-A445
‧ Evaluate the overall response rate (ORR) of BGB-A445 monotherapy in patients with selected advanced solid tumors according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Test Drug
BGB-A317BGB-A445
Active Ingredient
Tislelizumab
BGB-A445
BGB-A445
Dosage Form
concentrate for solution for infusion
concentrate for solution for infusion
concentrate for solution for infusion
Dosage
10 mg/mL
20 mg/mL
20 mg/mL
Endpoints
Phase 1a (dose escalation) Primary Objectives:
- Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the AE reporting period are classified by nature, frequency, severity (according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [NCI-CTCAE v5.0]), time, severity, and relevance to the trial treatment; laboratory abnormalities reported during the safety follow-up period are classified by nature, frequency, severity (according to NCI-CTCAE v5.0 classification), and time; AEs that meet the dose-limiting toxicity (DLT) criteria defined in the trial protocol
- MTD is defined as the highest tested dose at which the estimated probability of toxicity is closest to 30% of the target toxicity probability
- Potential Phase 2 recommended doses (RP2Ds) for BGB-A445 monotherapy and BGB-A445 plus tislelizumab will be determined based on the MTD or MAD, and will also take into account long-term tolerability, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data obtained
Phase 1b (dose expansion) Primary Objective: To evaluate safety, PK properties, pharmacodynamic properties, preliminary antitumor activity
and other relevant information obtained to determine the RP2D of BGB-A445
● ORR as assessed by trial sponsor based on tumor assessment according to RECIST v1.1
- Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) during the AE reporting period are classified by nature, frequency, severity (according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 [NCI-CTCAE v5.0]), time, severity, and relevance to the trial treatment; laboratory abnormalities reported during the safety follow-up period are classified by nature, frequency, severity (according to NCI-CTCAE v5.0 classification), and time; AEs that meet the dose-limiting toxicity (DLT) criteria defined in the trial protocol
- MTD is defined as the highest tested dose at which the estimated probability of toxicity is closest to 30% of the target toxicity probability
- Potential Phase 2 recommended doses (RP2Ds) for BGB-A445 monotherapy and BGB-A445 plus tislelizumab will be determined based on the MTD or MAD, and will also take into account long-term tolerability, PK, pharmacodynamics, preliminary antitumor activity, and other relevant data obtained
Phase 1b (dose expansion) Primary Objective: To evaluate safety, PK properties, pharmacodynamic properties, preliminary antitumor activity
and other relevant information obtained to determine the RP2D of BGB-A445
● ORR as assessed by trial sponsor based on tumor assessment according to RECIST v1.1
Inclution Criteria
Key Inclusion Criteria:
1. Phase 1a (dose escalation): Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused.
Enrollment will be limited to participants with advanced solid tumors for which there is clinical evidence of response to T cell based immuno-oncology agents (eg, anti PD 1) or other scientific evidence in support of an immunologically sensitive tumor type.
Participant has not received prior therapy targeting OX40 or any other T cell agonist therapy (prior checkpoint inhibitor therapy is allowed)
2. Phase 1b, the dose expansion phase, aims to include participants in specific tumor type cohorts who do not have access to standard systemic treatment, cannot tolerate it, or it is deemed inappropriate by the investigator. Cohort 1 focuses on non-small cell lung cancer (NSCLC) patients with advanced or metastatic disease, while Cohort 2 involves individuals with recurrent or metastatic head and neck squamous cell cancer (HNSCC). Cohort 3 includes participants with nasopharyngeal carcinoma (NPC), and Cohort 4 is for NSCLC patients with PD-L1 expression of at least 50%. Each cohort has specific eligibility criteria related to prior therapies, tumor characteristics, and treatment-free intervals.
3. Has at least 1 measurable lesion as defined per RECIST 1.1. The target lesion(s) selected have not been previously treated with local therapy OR the target lesion(s) selected that are within the field of prior local therapy have subsequently progressed as defined by RECIST 1.1 4. Participants should be able to provide tumor tissue sample 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 and a life expectancy of ≥ 6 months.
6. Adequate organ function as indicated by the following laboratory values up to first dose of study drug
a. Participants must not have required blood transfusion or growth factor support ≤ 14 days before sample collection for the following:
Absolute neutrophil count ≥ 1.5 x 10^9/L
Platelet count ≥ 75 x 10^9/L
Hemoglobin ≥ 90 g/L
b. Estimated glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 determined by the Cockcroft-Gault formula without correction for body surface area (BSA)
The estimated GFR for participants with renal cell carcinoma must be ≥ 30 mL/min/1.73 m^2 by the Cockcroft-Gault formula
c. Serum total bilirubin ≤ 1.5 x ULN (< 3 x ULN for participants with Gilbert syndrome) d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN;
≤ 5 x ULN for participants with hepatocellular carcinoma or liver metastases
1. Phase 1a (dose escalation): Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who have previously received standard systemic therapy or for whom treatment is not available, not tolerated or refused.
Enrollment will be limited to participants with advanced solid tumors for which there is clinical evidence of response to T cell based immuno-oncology agents (eg, anti PD 1) or other scientific evidence in support of an immunologically sensitive tumor type.
Participant has not received prior therapy targeting OX40 or any other T cell agonist therapy (prior checkpoint inhibitor therapy is allowed)
2. Phase 1b, the dose expansion phase, aims to include participants in specific tumor type cohorts who do not have access to standard systemic treatment, cannot tolerate it, or it is deemed inappropriate by the investigator. Cohort 1 focuses on non-small cell lung cancer (NSCLC) patients with advanced or metastatic disease, while Cohort 2 involves individuals with recurrent or metastatic head and neck squamous cell cancer (HNSCC). Cohort 3 includes participants with nasopharyngeal carcinoma (NPC), and Cohort 4 is for NSCLC patients with PD-L1 expression of at least 50%. Each cohort has specific eligibility criteria related to prior therapies, tumor characteristics, and treatment-free intervals.
3. Has at least 1 measurable lesion as defined per RECIST 1.1. The target lesion(s) selected have not been previously treated with local therapy OR the target lesion(s) selected that are within the field of prior local therapy have subsequently progressed as defined by RECIST 1.1 4. Participants should be able to provide tumor tissue sample 5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 and a life expectancy of ≥ 6 months.
6. Adequate organ function as indicated by the following laboratory values up to first dose of study drug
a. Participants must not have required blood transfusion or growth factor support ≤ 14 days before sample collection for the following:
Absolute neutrophil count ≥ 1.5 x 10^9/L
Platelet count ≥ 75 x 10^9/L
Hemoglobin ≥ 90 g/L
b. Estimated glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m^2 determined by the Cockcroft-Gault formula without correction for body surface area (BSA)
The estimated GFR for participants with renal cell carcinoma must be ≥ 30 mL/min/1.73 m^2 by the Cockcroft-Gault formula
c. Serum total bilirubin ≤ 1.5 x ULN (< 3 x ULN for participants with Gilbert syndrome) d. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN;
≤ 5 x ULN for participants with hepatocellular carcinoma or liver metastases
Exclusion Criteria
Key Exclusion Criteria:
Active leptomeningeal disease or uncontrolled brain metastasis. Participants with equivocal findings or with confirmed brain metastases are eligible for enrollment provided they are asymptomatic and radiologically stable without the need for corticosteroid treatment for at least 4 weeks prior to the first dose of study drug(s)
Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy, with the following exceptions:
Controlled type 1 diabetes
Hypothyroidism (provided it is managed with hormone-replacement therapy only)
Controlled celiac disease
Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
Any other disease that is not expected to recur in the absence of external triggering factors (requires consultation with the medical monitor prior to enrollment)
Any active malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast)
Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s), with the following exceptions:
Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption
Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
Any major surgical procedure occurring ≤ 28 days before the first dose of study drug(s). If surgical procedure occurs > 28 days, they must have recovered adequately from the toxicity
Active leptomeningeal disease or uncontrolled brain metastasis. Participants with equivocal findings or with confirmed brain metastases are eligible for enrollment provided they are asymptomatic and radiologically stable without the need for corticosteroid treatment for at least 4 weeks prior to the first dose of study drug(s)
Active autoimmune diseases or history of autoimmune diseases that may relapse or history of life-threatening toxicity related to prior immune therapy, with the following exceptions:
Controlled type 1 diabetes
Hypothyroidism (provided it is managed with hormone-replacement therapy only)
Controlled celiac disease
Skin diseases not requiring systemic treatment (eg, vitiligo, psoriasis, or alopecia)
Any other disease that is not expected to recur in the absence of external triggering factors (requires consultation with the medical monitor prior to enrollment)
Any active malignancy ≤ 2 years before the first dose of study drug(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast)
Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug(s), with the following exceptions:
Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent)
Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption
Short course (≤ 7 days) of corticosteroid prescribed prophylactically (eg, for contrast dye allergy) or for the treatment of a nonautoimmune condition (eg, delayed-type hypersensitivity reaction caused by contact allergen)
Any major surgical procedure occurring ≤ 28 days before the first dose of study drug(s). If surgical procedure occurs > 28 days, they must have recovered adequately from the toxicity
The Estimated Number of Participants
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Taiwan
40 participants
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Global
320 participants
