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BGB-283

Phase 1

Solid Tumors | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Dec 27, 2024

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 Trials2
Total Enrollment173
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03641586The Study of BGB-283 in Chinese Subjects With Local Advanced or Metastatic Malignant Solid TumorPHASE1 COMPLETED 42 — — Oct 12, 2015Mar 7, 2019Oct 23, 20241 China
NCT02610361Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid TumorsPHASE1 COMPLETED 131 — — Nov 20, 2013Oct 1, 2017Dec 27, 202419 Australia, New Zealand
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Study Endpoints
Primary Endpoints
Stage 1: Number of participants with treatment-related adverse events as assessed by CTC AE 4.03, 1 year in average
From signing the informed consent form and throughout the study, 1 year in average
Stage 2: To determine the objective response rate (ORR) as assessed by RECIST, Version 1.1
Every 6 weeks from first dose until the date of first documented progression or date of death from any cause, whichever came first, 1 year in average
Stage 3: Area under the plasma concentration-time curve from time 0 to infinity time (AUC)
Within 43 days since first dose
Stage 3: Maximum plasma concentration (Cmax)
Within 43 days since first dose
Stage 3: Terminal elimination half-life (t1/2)
Within 43 days since first dose
Stage 3: Detect Ka for Pop-PK analysis
Within 43 days since first dose
Stage 3: Detect CL/F for Pop-PK analysis
Within 43 days since first dose
Stage 3: Detect Vc/F for Pop-PK analysis
Within 43 days since first dose
Number of participants with adverse events in phase 1a
From first dose to within 28 days of last dose of BGB-283, within 1 years in average
Objective response rate based on RECIST Version 1.1 in subjects with selected tumor types in phase 1b
From the first administration of the investigational product to the end of the study treatment, within 1 year in average
Secondary Endpoints
Stage 1: Area under the plasma concentration-time curve from time 0 to infinity time (AUC)
Within 43 days since first dose
Stage 1: Maximum plasma concentration (Cmax)
Within 43 days since first dose
Stage 1: Terminal elimination half-life (t1/2)
Within 43 days since first dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Stage IEXPERIMENTALApproximately 25-35 Chinese subjects with local advanced or metastatic malignant solid tumor will be enrolled in the dose escalation stage of BGB-283 until maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) determination
Stage IIEXPERIMENTALApproximately 15-30 melanoma subjects will be enrolled in dose expansion stage of BGB-283
Stage IIIEXPERIMENTAL20 subjects will be enrolled for food effect stage of BGB-283
BGB-283EXPERIMENTAL -
Interventions
NameTypeDescription
BGB-283DRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Provided written informed consent prior to enrollment. 2. Male or female and between 18 and 75 years old. 3. A life expectancy of more than 12 weeks. 4. Stage I and III: Histologically or cytologically confirmed advanced or metastatic solid tumor for which no effective standa...

Countries:ChinaAustraliaNew Zealand
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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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