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Drug: BG-T187

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: May 29, 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 Enrollment153
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06598800Study of BG-T187 Alone and in Combination With Other Therapeutic Agents in Participants With Advanced Solid TumorsPHASE1 RECRUITING 153Oct 18, 2024Sep 30, 2028May 29, 202626 United States, Australia +2
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Study Endpoints
Primary Endpoints
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Approximately 2 years

Number of participants with AEs including serious adverse events (SAEs), defined as any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of study drugs, whether considered related to study drugs or not as graded by the National Cancer Institute-Common Terminology Criteria for Adverse Events \[NCI CTCAE) V5.0/American Society for Transplantation and Cellular Therapy (ASTCT) for cytokine release syndrome \[CRS\] and immune effector cell associated neurotoxicity syndrome \[ICANS\]); and adverse events meeting protocol-defined dose-limiting toxicity (DLT) criteria

Phase 1a: Maximum Administered Dose (MAD) or Maximum Tolerated Dose (MTD) of BG-T187
Approximately 2 years

MTD or MAD is defined as the highest dose evaluated for which the estimated toxicity rate is closest to the target toxicity rate of 30% or the highest dose administered, respectively.

Phase 1a: Recommended Dose(s) for Expansion (RDFE[s]) of BG-T187
Approximately 2 years

RDFE(s) is determined based on the MAD or MTD, taking into consideration the long-term tolerability, pharmacokinetics (PK), preliminary antitumor activity, and any other relevant data, as available

Phase 1b: Overall Response Rate (ORR)
Approximately 2 years

ORR is defined as the percentage of participants with confirmed best overall response (BOR) complete response (CR) or partial response (PR) as determined by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Phase 1b: Recommended Phase 2 dose (RP2D) of BG-T187 alone and in combination with other therapeutic agents
Approximately 2 years

R2PD is determined based on safety, tolerability, PK, preliminary antitumor activity, and other relevant data, as available

Secondary Endpoints
Phase 1a: ORR
Approximately 2 years
Phase 1a and 1b: Duration of Response (DOR)
Approximately 2 years
Phase 1a and 1b: Disease Control Rate (DCR)
Approximately 2 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1a: Part A: Monotherapy Dose Escalation with Intravenous AdministrationEXPERIMENTALSequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.
Phase 1a: Part B: Monotherapy Dose Escalation with Subcutaneous AdministrationEXPERIMENTALSequential cohorts of increasing dose levels of BG-T187 will be evaluated as monotherapy.
Phase 1a Part C: Safety ExpansionEXPERIMENTALBG-T187 dose levels that have been determined to be safe and tolerable in Part B will be investigated.
Phase 1b: Monotherapy Dose Expansion with Subcutaneous AdministrationEXPERIMENTALParticipants will receive BG-T187 monotherapy at the recommended dose(s) for expansion (RDFE) determined in Phase 1a.
Phase 1b: Combination Therapy: BG-T187 + Other Therapeutic AgentsEXPERIMENTALParticipants will receive BG-T187 in combination with Other Therapeutic Agents.
Interventions
NameTypeDescription
Drug: BG-T187DRUGadministered subcutaneously
Other Therapeutic AgentsDRUGadministered intravenously
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Participants must be ≥ 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place. 3. Eastern Cooperati...

Countries:United StatesAustraliaChinaSouth Korea
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT06598800lastUpdatePostDate: changed
LOWMay 29, 2026NCT06598800lastUpdatePostDate: changed
LOWMay 26, 2026NCT06598800Enrollment: 87 → 153
LOWMay 24, 2026NCT06598800studyFirstPostDate: changed