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BGB-A445

Phase 1

Urothelial Carcinoma | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: May 11, 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 Enrollment113
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05661955A Study to Investigate the Antitumor Activity, Safety, Tolerability, and Pharmacokinetics of BGB-A445 in Combination With Tislelizumab in Participants With Select Advanced Solid Tumors.PHASE1 ACTIVE NOT_RECRUITING 113Jan 9, 2023Oct 1, 2026May 11, 202618 China
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Study Endpoints
Primary Endpoints
Overall Response Rate (ORR) as Assessed by the Investigator
Up to approximately 26 months

ORR is defined as the percentage of participants who had confirmed complete response Complete Response (CR) or Partial Response (PR)

Secondary Endpoints
Disease-Control Rate (DCR)
Up to approximately 26 months
Clinical Benefit Rate (CBR)
Up to approximately 26 months
Number of Participants Experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to 30 days after the last dose of study drugs or the initiation of new anticancer therapy, whichever comes earlier, up to 22 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A: Previously Treated UCEXPERIMENTALBGB-A445 Monotherapy
Cohort B: Previously Treated UCEXPERIMENTALBGB-A445 and Tislelizumab
Cohort C: Previously Treated RCCEXPERIMENTALBGB-A445 Monotherapy
Cohort D: Previously Treated RCCEXPERIMENTALBGB-A445 and Tislelizumab
Cohort E: Previously Treated MelanomaEXPERIMENTALBGB-A445 Monotherapy
Cohort F: Previously Treated MelanomaEXPERIMENTALBGB-A445 and Tislelizumab
Cohort G: First Line Cisplatin Ineligible UCEXPERIMENTALBGB-A445 and Tislelizumab
Cohort H: First Line Non-mucosal MelanomaEXPERIMENTALBGB-A445 and Tislelizumab
Cohort I: Previously Treated Non-mucosal MelanomaEXPERIMENTALBGB-A445 and Tislelizumab
Interventions
NameTypeDescription
BGB-A445DRUGadministered intravenously
TislelizumabDRUGadministered intravenously
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites18

Key Inclusion Criteria: 1. Participants who were histologically or cytologically confirmed advanced and/or metastatic cancer. UC participants (Cohort A and B), RCC patients (Cohort C and D) or melanoma participants (Cohort E and F) who have received at least 1 but no more than 3 lines of prior syst...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05661955primaryCompletionDate: changed
LOWMay 24, 2026NCT05661955studyFirstPostDate: changed