Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BC3195 · 1 trial · 1 indication
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.
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).
| Arm | Type | Description |
|---|---|---|
| BC3195 in Combination with Pembrolizumab | EXPERIMENTAL | The 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). |
| Name | Type | Description |
|---|---|---|
| BC3195 | DRUG | BC3195 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® | DRUG | Pembrolizumab 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. |
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...
BC3195 is an investigational small molecule being studied for the treatment of locally advanced or metastatic solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BC3195 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK on the New York Stock Exchange.
BC3195 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for any use.
BC3195 is being studied in a Phase 1 clinical trial with the identifier NCT07469774. This trial evaluates BC3195 in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors and is expected to enroll 111 participants in China.
BC3195 is being studied in combination with pembrolizumab. The ongoing Phase 1 trial, NCT07469774, is an uncontrolled, open-label study testing this combination in patients with locally advanced or metastatic solid tumors.