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BC3195

Phase 1

Locally Advanced or Metastatic Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Mar 13, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment111
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07469774BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid TumorsPHASE1 NOT YET_RECRUITING 111 — — Mar 17, 2026Dec 31, 2028Mar 13, 20261 China
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Study Endpoints
Primary Endpoints
Number of partcipants with Dose Limiting Toxicities (DLTs)
Throughout the dose escalation phase, an average of 1 year

The incidence of dose-limiting toxicity (DLT) at different doses of BC3195 combined with pembrolizumab in patients with locally advanced or metastatic solid tumors. DLT will be assessed at the end of Cycle 1.

Investigator-assessed Objective Response Rate (ORR) of BC3195 combined with pembrolizumab in participants with solid tumors
Throughout the dose expansion phase, an average of 2.5 years

ORR (per investigator's assessment based on RECIST v1.1) defined as the proportion of participants who achieve a best overall response (BOR) of complete response (CR) or partial response (PR).

Secondary Endpoints
Investigator-assessed progression-free survival (PFS) of BC3195 combined with pembrolizumab in participants with solid tumors
Through study completion, an average of 2.5 years
Investigator-assessed disease control rate (DCR) of BC3195 combined with pembrolizumab in participants with solid tumors
Through study completion, an average of 2.5 years
Investigator-assessed duration of response (DOR) of BC3195 combined with pembrolizumab in participants with solid tumors
Through study completion, an average of 2.5 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BC3195 in Combination with PembrolizumabEXPERIMENTALThe study is divided into two phases: the dose escalation phase (Phase I): BC3195 (with 3 preset dose cohorts: 1.8mg/kg, 2.1mg/kg, 2.4mg/kg Q3W) combined with pembrolizumab (200mg Q3W) will be enrolled sequentially; the dose expansion (Phase II) phase: the recommended Phase 2 dose (RP2D) for BC3195 from the dose escalation phase combined with pembrolizumab (200mg Q3W) will be used in 4 cohorts (NSCLC / TNBC / HNSCC /others).
Interventions
NameTypeDescription
BC3195DRUGBC3195 for injection is a sterile lyophilized powder in a 20 mg single-dose vial. Administration: Administered via intravenous (IV) infusion, with dosing and frequency determined according to Phase I (dose escalation) and Phase Ⅱ(dose expansion) study design
Pembrolizumab/KEYTRUDA®DRUGPembrolizumab will be administered at 200 mg as a 30 minute IV infusion Q3W prior to BC3195. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Provide written informed consent. 2. Aged at least 18 years at the time of ICF signature. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to the first dose of study treatment. 4. Life expectancy of ≥ 3 months based on the In...

Countries:China
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07469774studyFirstPostDate: changed