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BG-C0902

Phase 1

Solid Tumors | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: May 26, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment63
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07181681A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeutic Agents in Patients With Advanced Solid TumorsPHASE1 RECRUITING 63 — — Nov 10, 2025Nov 1, 2027May 26, 202614 United States, Australia +1
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Study Endpoints
Primary Endpoints
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Approximately 24 Months
Phase 1a: Number of Participants with Dose Limiting Toxicities (DLTs)
Approximately 21 Days
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BG-C0902
Approximately 24 Months

MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.

Phase 1a: Recommended dose(s) for Expansion (RDFE) of BG-C0902
Approximately 24 Months

RDFE of BG-C0902 will be determined based upon the MTD or MAD.

Phase 1b: Recommended Phase 2 Dose (RP2D) of BG-C0902 as Monotherapy
Approximately 24 Months

RP2D as determined based on safety, pharmacokinetics (PK), pharmacodynamics, preliminary antitumor activity, and other relevant data, as available.

Phase 1b: Overall Response Rate (ORR)
Approximately 24 Months

ORR is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) as determined from tumor assessments by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Secondary Endpoints
Phase 1a: ORR
Approximately 24 Months
Phase 1a and 1b: Duration of Response (DOR)
Approximately 24 Months
Phase 1a and 1b: Disease Control Rate (DCR)
Approximately 24 Months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a: Dose Escalation and Safety Expansion of BG-C0902EXPERIMENTALSequential cohorts of increasing dose levels of BG-C0902 will be evaluated as monotherapy.
Phase 1b: Dose Expansion of BG-C0902EXPERIMENTALThe recommended dose(s) for expansion (RDFE) for BG-C0902 from Part 1 will be evaluated in selected tumors.
Interventions
NameTypeDescription
BG-C0902DRUGAdministered by intravenous infusion
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors not amenable to therapy with curative intent or for whom treatment is not available or not tolerated. * Participants must be able to provide archival tissue formalin-...

Countries:United StatesAustraliaChina
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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Recent Changes (Last 90 Days)
LOWMay 27, 2026NCT07181681lastUpdatePostDate: changed
LOWMay 27, 2026NCT07181681lastUpdatePostDate: changed
LOWMay 26, 2026NCT07181681primaryCompletionDate: changed
LOWMay 24, 2026NCT07181681studyFirstPostDate: changed