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BGB-B455

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: May 22, 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 Enrollment90
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06803680A Study of BGB-B455 in Adults With Advanced or Metastatic Solid TumorsPHASE1 RECRUITING 90 — — Mar 18, 2025Apr 29, 2028May 22, 202613 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)
From the first dose of study drug(s) to 30 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 7 months

Number of participants with AEs and SAEs, including laboratory abnormalities, and AEs that meet protocol-defined dose-limiting toxicity (DLT) criteria or protocol-defined adverse events of special interest (AESI) criteria.

Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-B455
Approximately 1 month

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: RDFE of BGB-B455
Approximately 1 month

RDFE of BGB-B455 will be determined based upon the MTD or MAD.

Phase 1b: Overall Response Rate (ORR)
Approximately 18 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 investigator per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1). CR and PR must be confirmed by repeat assessments.

Secondary Endpoints
Phase 1a: ORR
Approximately 18 months
Phase 1a and 1b: Duration of Response (DOR)
Approximately 18 months
Phase 1a and 1b: Disease Control Rate (DCR)
Approximately 18 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a: Dose Escalation and Safety ExpansionEXPERIMENTALSequential cohorts of increasing dose levels of BGB-B455 will be evaluated as monotherapy.
Phase 1b: Dose ExpansionEXPERIMENTALRecommended Dose(s) for Expansion (RDFE\[s\]) of BGB-B455 determined from Phase 1a as monotherapy or in combination with investigator-selected chemotherapy will be evaluated for selected indications based on emerging data.
Interventions
NameTypeDescription
BGB-B455DRUGPlanned doses administered on specified days per protocol.
ChemotherapyDRUGAdministered in accordance with relevant local guidelines and/or prescribing information.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * Histologically or cytologically confirmed advanced or metastatic, and unresectable solid tumors who have previously received standard systemic therapy for advanced or metastatic disease or for whom treatment is not available or not tolerated. Only participants with CLDN6+ high...

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)
MEDIUMMay 26, 2026NCT06803680primaryCompletionDate: changed
LOWMay 24, 2026NCT06803680studyFirstPostDate: changed