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

NCT07469774 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

  • Locally Advanced or Metastatic Solid Tumors

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-17
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07469774 on ClinicalTrials.gov