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A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started2024-07-23
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 4 changed
See other at-risk trials from BeOne Medicines

Amendment history

2026-09-02
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v22
Phase changed: Phase 1 → Phase 1/2
Primary endpoint(s) modified4 entries, revised
WasPart A and B: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033, Part A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Part A and B: Recommended Phase 2 dose (RP2D) of BGB-B2033, Part C and D: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
NowPart A and B: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033, Part A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Part A and B: Recommended Phase 2 dose (RP2D) of BGB-B2033, Parts C, D, and E: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
Enrollment increased: 392 → 630 participants
Trial arms changed: 6 → 7
Primary completion moved earlier: 2028-05-30 → 2027-03-31
Completion pushed: 2028-05-30 → 2028-10-31
Study sites48→49
Eligibility criteriarevised
[...] CPI). At least one evaluable lesion for dose escalation, and At at least one measurable lesion for safety expansion, as define [...]
Secondary endpoints11 entries, revised
PartParts C, D, and DE: Overall Response Rate (ORR) as assessed by the investigatorInvestigator PartParts C, D, and DE: Duration of Response (DOR) as assessed by the investigator and IRC PartParts C, D, and DE: Progression Free Survival (PFS) as assessed by the investigator and IRC PartAll C and DParts: Overall Survival (OS) PartParts C, D, and DE: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study title+2 characters
A Phase 1/2 Study of BGB-B2033, Alone or in Combination With Tislelizum [...]
2026-07-28
Study Status, Contacts/Locations v21
Study sites47→48
2026-07-06
Study Status, Contacts/Locations v20
Study sites46→47
2026-06-01
Study Status, Contacts/Locations v19
Trial sites expanded: 29 → 46 locations
2026-05-12
Study Identification, Study Status, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v18
Primary endpoint(s) modified3 to 4 entries
WasMaximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033, Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Recommended Phase 2 dose (RP2D) of BGB-B2033
NowPart A and B: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B2033, Part A and B: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Part A and B: Recommended Phase 2 dose (RP2D) of BGB-B2033, Part C and D: Overall Response Rate (ORR) as assessed by the Independent Review Committee (IRC)
Enrollment increased: 140 → 392 participants
Trial arms changed: 2 → 6
Trial sites expanded: 20 → 29 locations
Primary completion pushed: 2026-10-30 → 2028-05-30
Completion pushed: 2026-12-31 → 2028-05-30
Secondary endpoints6 to 11 entries
Part A and B: Overall Response Rate (ORR) as assessed by the investigator Part A and B: Duration of Response (DOR) as assessed by the investigator Part A and B: Disease Control Rate (DCR) as assessed by the investigator Part A and B: Progression Free Survival (PFS) as assessed by the investigator Part A and B: Serum concentration of of BGB-B2033 Part A and B: Number of participants with anti-drug antibodies (ADAs) to BGB-B2033 Part C and D: Overall Response Rate (ORR) as assessed by the investigator Part C and D: Duration of Response (DOR) as assessed by the investigator and IRC Part C and D: [...]
Show 17 earlier versions
2026-04-16
Study Identification, Study Status v17
Re-verified, no change to tracked fields
2026-04-14
Study Status, Contacts/Locations v16
Study sites19→20
2026-03-17
Study Status, Contacts/Locations v15
Study sites16→19
2026-03-04
2 amendments v13-v14
2 re-verifications since 2026-01-09, no change to tracked fields
2025-12-10
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, IPDSharing v12
Completion date2026-10-30→2026-12-31
Study sites15→16
Lead sponsorBeiGene→BeOne Medicines
InterventionsBGB-B2033 (Drug), Tislelizumab (Drug)→BGB-B2033 (Drug), Bevacizumab (Drug), Tislelizumab (Drug)
Eligibility criteria+839 characters
Key Inclusion Criteria: Participants withmust anyhave one of the following unresectable, locally advanced, or metastatic tumor types: Hepatocellular carcinoma (HCC): Histologically or cytologically confirmed HCC that is either Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not amenable to, or has progressed after, loco-regional therapy and is not eligible for a curative treatment approach. Alpha-fetoprotein (AFP)-producing gastric cancer (GC): Histologically confirmed GC (serumwith AFP > 20 ng/mL in blood or tumor tissue positive for AFP positive by a validated immunohis [...] [...]
Secondary endpoints6 entries, revised
Serum concentration of of BGB-B2033
Primary endpoints3 entries, revised
Recommended Phase 2 dose (RP2D) of BGB-B2033 alone and in combination with tislelizumab
Study title+28 characters
A Phase 1 Study of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Advanced or Metastatic Solid Tumors
2025-10-22
Study Identification, Study Status, Contacts/Locations v11
Study sites15 entries, revised
MemorialThe SloanSecond KetteringAffiliated CancerHospital Centerof MskccNanchang Universityhongjiaozhou Branch
2025-09-18
Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 15 sites
2025-07-09
Study Status, Contacts/Locations v9
Study sitesdetails revised at 1 of 15 sites
2025-04-15
Study Status, Contacts/Locations v8
Study sitesdetails revised at 6 of 15 sites
2025-03-31
Study Status, Contacts/Locations v7
Study sitesdetails revised at 1 of 15 sites
2025-02-25
Study Status, Contacts/Locations v6
Study sites14→15
2025-02-02
Study Status, Contacts/Locations v5
Study sitesdetails revised at 1 of 14 sites
2025-01-10
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v4
Study sitesdetails revised at 3 of 14 sites
Study titlerevised
A Phase 1 Study of BGB-B2033, Alone or in Combination withWith Tislelizumab, in Participants withWith Advanced or Metastatic Solid Tumors
2024-12-16
Study Identification, Study Status, Oversight, Conditions, Contacts/Locations v3
Study sites3→14
Study titlerevised
A Phase 1 Study of BGB-B2033, Alone or in Combination Withwith Tislelizumab, in Participants Withwith Advanced or Metastatic Solid Tumors
2024-09-27
Not Yet Recruiting→Recruiting Study Status, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-07→confirmed 2024-07-23
Study sites0→3
Eligibility criteria-191 characters
Inclusion Criteria: Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 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). Participants with any of the following unresectable locally advanced or metastatic tumor types: HCC Histologically confirmed AFP-producing GC (serum AFP > 20 ng/mL or tumor tissue AFP p [...] a validated IHC assay according to local testing criteria) Histologically confirmed germ cell tumor including ext [...] [...]
Secondary endpointsdetails revised at 4 of 6 entries
2024-06-24
Study Status v1
Start date2024-05-23→2024-07
2024-05-20
Original filing
BeOne Medicines
59 trials monitored
See 7 trials at risk
Lung Cancer
4,033 trials monitored
See 210 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
2,914 trials monitored
See 156 trials at risk
Liver Cancer
1,505 trials monitored
See 60 trials at risk
and 1 more disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of BGB-B2033 alone or in combination with tislelizumab, with or without bevacizumab, in adults 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 determine the recommended Phase 2 dose (RP2D) of BGB-B2033 when given alone or in combination with tislelizumab and bevacizumab. The main questions it aims to answer are: * Is BGB-B2033 safe and tolerable when given alone or in combination with tislelizumab, with or without bevacizumab? * How does the body process BGB-B2033, and what are its effects on the body? * Does BGB-B2033 show preliminary antitumor activity in participants with advanced or metastatic cancer? Researchers will evaluate different doses and treatment combinations to determine the safest and most appropriate dose of BGB-B2033 for further study. Participants will: * Receive BGB-B2033 by intravenous infusion, either alone or in combination with tislelizumab, with or without bevacizumab. * Have regular assessments to monitor safety, side effects, how their body processes and responds to BGB-B2033, and whether their cancer responds to treatment.
Trial Details
NCT Number NCT06427941
Lead Sponsor BeOne Medicines
Conditions Metastatic Hepatocellular Carcinoma, Local Advanced Hepatocellular Carcinoma, Alpha-fetoprotein (AFP)-Producing Gastric Cancer, Extragonadal Yolk Sac Tumors, Glypican-3 (GPC3)-Positive Squamous Non-small Cell Lung Cancer
Enrollment 630 participants
Start Date 2024-07-23
Primary Completion 2027-03-31 (estimated)
Study Completion 2028-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-09-16