BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

Sponsor
Biocity Biopharmaceutics Co., Ltd.
Study ID
NCT07469774
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

This is a Phase 1/2, open-label, dose escalation and expansion study to assess the safety, pharmacokinetics, and preliminary efficacy of BC3195 in combination with pembrolizumab in participants with locally advanced or metastatic solid tumors.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
111 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BC3195 in Combination with Pembrolizumab
    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).

Primary Outcome Measure

Number of partcipants with Dose Limiting Toxicities (DLTs) [ Time Frame: Throughout the dose escalation phase, an average of 1 year ]

Central Contacts

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