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The study was terminated by the sponsor for reasons unrelated to safety.
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The purpose of this study is to evaluate the safety, tolerability, and antitumor activity of BGB-3245 in participants with advanced or refractory solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a: Dose Escalation | Experimental | BGB-3245 administered orally (PO) |
|
| Phase 1b, Group 1: Dose Expansion | Experimental | BGB-3245 administered orally (PO) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-3245 | Drug | administered orally (PO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Number of Participants and Severity Experiencing Adverse Events (AEs) | Up to 30 days after the last dose of study drug | |
| Phase 1a: Number of Participants and Severity Experiencing Serious Adverse Events (SAEs) | Up to 30 days after the last dose of study drug | |
| Phase 1a: number of Participants Experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria | From Cycle 1 Day to the end of Cycle 1 (Cycle 1 is 30 days) | |
| Phase 1a: Maximum Tolerated Dose (MTD) of BGB-3245, and the recommended Phase 2 Dose (RP2D) for BGB-3245 | The MTD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33%. | From Cycle 1 Day to the end of Cycle 1 (Cycle 1 is 30 days) |
| Phase 1b: Recommended Phase 2 dose (RP2D) of BGB-3245 | The highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 33% | From Cycle 1 Day to the end of Cycle 1 (Cycle 1 is 30 days) |
| Phase 1b: Objective Response Rate (ORR) as assessed by the investigator | ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator | Up to 24 months |
| Phase 1b: Further review of the ORR | ORR is defined as the percentage of participants with partial or complete response in up to 15 participants with tumors harboring BRAF fusion mutations |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1a: Overall Response Rate (ORR) as Assessed by the Investigator | Up to 24 months | |
| Phase 1a: Duration of Response (DOR) as Assessed by the Investigator | Up to 24 months | |
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Key Inclusion Criteria:
Participants with histologically confirmed advanced or metastatic solid tumor who had disease progression during or after systemic anticancer therapies that previously demonstrated clinical benefit (eg, improved survival) in a representative population, or are unable to receive standard therapy(ies). In addition, participants must meet the following eligibility criteria for the corresponding phase of the study:
I. Group 1: participants with tumor types other than CRC that harbor BRAF V600 mutations who have been treated and progressed on prior BRAF and/or mitogen activated protein kinase (MEK) inhibition.
II. Group 2: participants with advanced solid tumors harboring a BRAF Class II mutation or a BRAF fusion mutation.
III. Group 2 BRAF Fusion Expansion: Participants with advanced solid tumors harboring a BRAF fusion mutation
Participants must provide archival tumor tissue or agree to a fresh tumor biopsy for mutation and biomarkers analysis (fresh tumor biopsies are strongly recommended)
Participants must have radiologically measurable disease as defined by RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Adequate organ function and no transfusions within 14 days of first dose
Key Exclusion Criteria :
Participants receiving cancer therapy (chemotherapy or other systemic anticancer therapies, immunotherapy, radiation therapy, or surgery) at the time of Cycle 1 Day 1.
All participants who have received prior systemic anticancer treatment within the following time frames will be excluded:
Severe or uncontrolled systemic disease.
Clinically significant cardiac disease within 6 months of signing the ICF
CNS metastases, leptomeningeal carcinomatosis or untreated spinal cord compression.
Any unstable, preexisting major medical condition, including known human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Systemic anti-cancer therapy within 2 weeks or 5 half-lives before first dose.
Major surgical procedure or significant traumatic injury within 4 weeks prior to the first dose or anticipates need for major surgery while on study.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Beverly Hills | California | 90212 | United States | ||
| Massachusetts General Hospital |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 3, 2026 | |
| Reset | Mar 23, 2026 | |
| Release | Apr 14, 2026 |
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| Up to 24 months |
| Phase 1a: Clinical Benefit Rate (CBR) as Assessed by the Investigator |
| Up to 24 months |
| Phase 1a: Best Overall Response (BOR) as Assessed by the Investigator | Up to 24 months |
| Phase 1a: Duration of Stable Disease (DSD) | Up to 24 months |
| Phase 1a: Progression Free Survival (PFS) | Up to 24 months |
| Phase 1a: Plasma Concentration of BGB-3245 | Within 60 minutes predose up to 72 hours postdose |
| Phase 1a: Maximum Observed Plasma Concentration (Cmax) of BGB-3245 | Within 60 minutes predose up to 72 hours postdose |
| Phase 1a: Time to Maximum Plasma Concentration (Tmax) of BGB-3245 | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Time Taken for Half the Initial Dose Administered To Be Eliminated From The Body (T1/2) of BGB-3245 | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Area Under the Concentration-Time Curve of 0-infinity Days (AUC0-inf) of BGB-3245 | 60 minutes predose up to 72 hours postdose |
| Phase 1a:Area Under the Concentration-Time Curve of 0-Last hour (AUC0-last) of BGB-3245 | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Drug Clearance (CL/F) of BGB-3245 | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Apparent Volume of Distribution (Vz/F) of BGB-3245 | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Steady State Area Under the Concentration-Time Curve of 0- Last hour (AUCLast, ss) of BGB-3245 | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Steady State Maximum Observed Plasma Concentration (Cmax, ss) of BGB-3245 | 60 minutes predose up to 72 hours postdose |
| Phase 1a: Steady State Time to Maximum Plasma Concentration (Tmax, ss) of BGB-3245 | 60 minutes predose up to 72 hours postdose |
| Phase 1b: Progression-free survival (PFS) as Assessed by the Investigator | Up to 36 months |
| Phase 1b: Duration of Response (DOR) as Assessed by the Investigator | Up to 24 months |
| Phase 1b: Disease-Control Rate (DCR) as Assessed by the Investigator | Up to 24 months |
| Phase 1b: Duration of Stable Disease (DSD) as Assessed by the Investigator | Up to 24 months |
| Phase 1b: Clinical Benefit Rate (CBR) as Assessed by the Investigator | Up to 24 months |
| Phase 1b: Overall Survival | Up to 36 months |
| Phase 1b: Number of Participants Experiencing Adverse Events (AEs) | Up to 30 days after the last dose of study drug |
| Phase 1b: Number of Participants Experiencing Serious Adverse Events (SAEs) | Up to 30 days after the last dose of study drug |
| Phase 1b: Plasma Concentration of BGB-3245 | 60 minutes predose up to 3 hours postdose |
| Phase 1b: Steady State Trough Observed Plasma Concentration (Ctrough, SS) of BGB-3245 | 60 minutes predose up to 72 hours postdose |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| MD Anderson | Houston | Texas | 77030 | United States |
| University of Virginia Comprehensive Cancer Centre | Charlottesville | Virginia | 22903 | United States |
| Blacktown Hospital | Blacktown | New South Wales | 2148 | Australia |
| The Kinghorn Cancer Centre, St Vincent Hospital Sydney | Sydney | New South Wales | 2010 | Australia |
| One Clinical Research | Nedlands | Perth | 6009 | Australia |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | 2010 | Australia |
| Reset | May 4, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 3, 2026 | Mar 23, 2026 | |||
| Apr 14, 2026 | May 4, 2026 | |||
| Jul 6, 2026 |