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BGB-283

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials2
Total Enrollment173

FDA Designations

No designations recorded

Clinical trial landscape

BGB-283 · 2 trials · 1 indication

Phase 1 2
NCT03641586The Study of BGB-283 in Chinese Subjects With Local Advanced or Metastatic Malignant Solid TumorSolid Tumors
COMPLETED42 Analytics
NCT02610361Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid TumorsSolid Tumors
COMPLETED131 Analytics
PHASE1COMPLETED
The Study of BGB-283 in Chinese Subjects With Local Advanced or Metastatic Malignant Solid Tumor
Solid Tumors
NCT0364158642
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PHASE1COMPLETED
Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid Tumors
Solid Tumors
NCT02610361131
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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 to 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 (matched to "Solid Tumors")

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
AstraZeneca PLCAZN1 - Trastuzumab deruxtecan
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Frequently asked questions about BGB-283

What is BGB-283 used for?

BGB-283 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development and has been studied in patients with solid tumors, including those with locally advanced or metastatic disease. The drug is not yet approved and remains under investigation.

Who makes BGB-283?

BGB-283 is being developed by BeOne Medicines Ltd., a biopharmaceutical company traded under the ticker ONC. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of BGB-283 in patients with solid tumors.

What phase is BGB-283 in?

BGB-283 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, with a total enrollment of 173 patients, but the drug remains in early-stage clinical investigation.

What clinical trials is BGB-283 in?

BGB-283 has been studied in two completed Phase 1 trials. The first trial, NCT02610361, enrolled 131 patients with solid tumors in Australia and New Zealand. The second trial, NCT03641586, enrolled 42 Chinese subjects with locally advanced or metastatic malignant solid tumors.

Is BGB-283 the same as any other drug?

BGB-283 is a distinct investigational compound and no alternative names have been reported for it. It is being studied under its own name in clinical trials for solid tumors, and there are no known aliases or other designations associated with this drug.