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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06427941
Other study ID # BGB-B2033-101
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date May 23, 2024
Est. completion date October 30, 2026

Study information

Verified date May 2024
Source BeiGene
Contact Study Director
Phone 1.877.828.5568
Email clinicaltrials@beigene.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a first-in-human (FIH) Phase 1 study of BGB-B2033 to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of the BGB-B2033 in participants with advanced or metastatic hepatocellular carcinoma (HCC), alpha-fetoprotein (AFP)-producing gastric cancer (GC), extragonadal yolk sac tumors, non-dysgerminomas, or glypican-3 (GPC3)-positive squamous non-small cell lung cancer (NSCLC). The study will also identify the recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab for subsequent proof-of-concept studies. BGB-B2033 will be administered by intravenous infusion. The Phase 1 study will be conducted in 2 parts: Part A (Monotherapy Dose Escalation and Safety Expansion) and Part B (Combination Dose Escalation and Safety Expansion).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 140
Est. completion date October 30, 2026
Est. primary completion date October 30, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Age = 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place, whichever is older). 3. Participants with any of the following unresectable locally advanced or metastatic tumor types: 1. HCC 2. Histologically confirmed AFP-producing GC (serum AFP > 20 ng/mL or tumor tissue AFP positive by a validated IHC assay according to local testing criteria) 3. Histologically confirmed germ cell tumor including extragonadal yolk sac tumors located in mediastinum, vagina, brain, and retroperitoneum, etc) and non-dysgerminomas 4. Histologically confirmed GPC3-positive squamous NSCLC 4. = 1 evaluable lesion for dose escalation and = 1 measurable lesion for safety expansion, per RECIST v1.1 5. ECOG Performance Status score = 1 Exclusion Criteria: 1. Prior therapy targeting glypican-3 (GPC3) or the T-cell costimulatory receptor 4-1BB (also known as CD137) 2. Active leptomeningeal disease or uncontrolled, untreated brain metastasis 3. Active autoimmune diseases or history of autoimmune diseases that may relapse 4. Any 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 5. 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). Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
BGB-B2033
Administered by intravenous infusion
Tislelizumab
Administered by intravenous infusion

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
BeiGene

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Number of participants with AEs and SAEs characterized by type, frequency, severity (as graded by the National Cancer Institute- Common Terminology Criteria for Adverse Events Version 5.0 [NCI-CTCAE v 5.0/American Society for Transplantation and Cellular Therapy [ASTCT] for cytokine release syndrome [CRS] and immune effector cell-associated neurotoxicity syndrome [ICANS]), timing, seriousness, and relationship to study therapy; assessment of adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria; Up to approximately 2 years
Primary Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033 The MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to a target toxicity rate of 30% or the highest dose administered, respectively. Up to approximately 2 years
Primary Recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab The RP2D(s) will be determined based on a biologically effective dose by taking the totality of available preclinical and clinical data, including safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and antitumor activity, into consideration Up to approximately 2 years
Secondary Overall Response Rate (ORR) ORR is defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Up to approximately 2 years
Secondary Duration of Response (DOR) DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator. Up to approximately 2 years
Secondary Disease Control Rate (DCR) DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease as determined from tumor assessments by the investigator using RECIST v1.1. Up to approximately 2 years
Secondary Progression Free Survival (PFS) PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first. Up to approximately 2 years
Secondary Serum concentration of BGB-B2033 Up to approximately 2 years
Secondary Number of participants with anti-drug antibodies (ADAs) to BGB-B2033 Up to approximately 2 years
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