NCT07469774

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

A Phase 1/2, Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Preliminary Efficacy of BC3195 in Combination With Pembrolizumab in Participants With Locally Advanced or Metastatic Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 111 (estimated)
• Sponsor: Biocity Biopharmaceutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 pembroliaumab in participants with locally advanced or metastatic solid tumors.

Detailed description

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 pembroliaumab in participants with locally advanced or metastatic solid tumors. This study consists of two parts: A dose escalation part (Part 1) and a dose expansion part (Part 2). Each part will include a screening period, a treatment period, and follow-up period.

Conditions

• Locally Advanced or Metastatic Solid Tumors

Interventions

Type	Name	Description
DRUG	BC3195	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
DRUG	Pembrolizumab/KEYTRUDA®	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.

Timeline

• Start date: 2026-03-17
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

1 site across 1 country: China