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

NCT07469774 | Not Yet Recruiting Phase 1

• 4 other identifiers: BC3195-103CTR20260447MK-3475-G36KEYNOTE-G36
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Solid Tumors

Outcome Measures

Primary Outcomes (2)

• Number of partcipants with Dose Limiting Toxicities (DLTs)

  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.

  Throughout the dose escalation phase, an average of 1 year

• Investigator-assessed Objective Response Rate (ORR) of BC3195 combined with pembrolizumab in participants with solid tumors

  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).

  Throughout the dose expansion phase, an average of 2.5 years

Secondary Outcomes (13)

• 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

• Overall survival (OS) of BC3195 combined with pembrolizumab in participants with solid tumors

  Through study completion, an average of 3 years

• Number of partcipants with treatment emergent adverse events (TEAEs)

  Through study completion, an average of 3 year

Study Arms (1)

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).

Drug: BC3195; Drug: Pembrolizumab/KEYTRUDA®

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

BC3195 in Combination with Pembrolizumab

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.

BC3195 in Combination with Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent.
• Aged at least 18 years at the time of ICF signature.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 within 7 days prior to the first dose of study treatment.
• Life expectancy of ≥ 3 months based on the Investigator's assessment.
• Participants in Dose escalation part must meet the following criteria: Histologically or cytologically confirmed advanced/metastatic solid tumor by pathology report and have received, or been intolerant to, all treatment known to confer clinical benefit, including but not limited to: NSCLC, BC, HNSCC, ESCC, EMC, UC, CRC, OC, and prostate cancer. The sponsor or designee must approve eligibility for malignancies other than those specifically mentioned above.
• Participants in Dose expansion part must meet one of the following criteria:
• For NSCLC (cohort 1):
• Participants have pathologically documented Stage IIIB, IIIC, or Stage IV NSCLC without actionable genomic alterations (AGA) based on the American Joint Committee on Cancer, Eighth Edition (Participants must have documented negative test results for EGFR and ALK genomic alterations and have no known genomic alterations in ROS1, NTRK, BRAF, MET exon 14 skipping, or RET) and meet one of the following criteria:
• Locally advanced or metastatic NSCLC participants relapsed or refractory to at least 1 prior line of therapy including platinum-based chemotherapy in combination with or without anti-PD(L)1 antibody; OR
• Locally advanced or metastatic NSCLC participants relapsed or refractory to at least 2 prior lines of therapy including anti-PD(L)1 antibody and platinum-based chemotherapy sequentially.
• For TNBC (cohort 2):
• Participants have histologically or cytologically confirmed TNBC per ASCO/CAP criteria based on the most recent analyzed biopsy or other pathology specimen and meets the following criteria: Relapsed or refractory to 2 or more prior systemic regimens for unresectable, locally advanced or metastatic disease (-For prior therapy, 1 could be in the (neo)adjuvant setting, provided progression occurred during treatment or within 12 months after treatment discontinuation;-Received taxane(s) in any setting).
• For HNSCC (cohort 3):
• Participants have histologically or cytologically confirmed locally advanced or metastatic HNSCC and meet one of the following criteria:
• Relapsed or refractory to at least 1 prior line of therapy including platinum-based chemotherapy with cetuximab, or platinum-based chemotherapy with or without anti-PD(L)1 antibody. OR

You may not qualify if:

• Has received prior systemic anticancer treatment, including investigational agents, within 5 half-lives or 4 weeks prior to the first dose of study treatment (whichever is shorter). Has received Traditional Chinese Medication within 7 days prior to study treatment.
• Participants who have received major surgery (defined as requiring general anesthesia and \>24-hour inparticipant hospitalization) within 4 weeks prior to the first dose of study treatment. Participant must have recovered adequately from complications from the intervention prior to starting study treatment.
• Has received prior radiotherapy within 2 weeks of start of study treatment or have had a history of radiation pneumonitis.
• Note: Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
• Has had an allogeneic tissue/solid organ transplant.
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
• Has known active CNS metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable (ie, without evidence of progression) for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study treatment.
• Has clinically uncontrolled pericardial effusion, pleural effusion, or ascites at screening.
• Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
• Active viral infection requiring systemic therapy during the screening period.
• Hypertension that cannot be well-controlled with medical treatment. Not well-controlled is defined as systolic blood pressure \>150 mmHg or diastolic blood pressure \>95 mmHg (adjustment of hypertensive medication prior to study initiation is permitted, but the mean of the most recent three consecutive blood pressure records prior to study entry must be ≤150/95 mmHg \[with at least 2- minute interval between each measurement\]).
• Cardiovascular disease of clinical significance: Including New York Heart Association \[NYHA\] Class II-IV, congestive heart failure, second-degree or higher heart block, myocardial infarction within the past 3 months, unstable arrhythmia or unstable angina, marked QT interval prolongation (12-lead ECG showing baseline-corrected QTc interval \>480 ms), cerebral infarction within 3 months, or having received PTCA or CABG within 6 months.
• Participants with active or chronic corneal disorders, with other active ocular conditions requiring ongoing therapy or with any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
• Participants with any active infection that requires systemic anti-infective therapy judged by the investigators.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.

Sponsors & Collaborators

• Biocity Biopharmaceutics Co., Ltd.: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

pembrolizumab

Central Study Contacts

Yilong Wu

CONTACT

020-83827812; syylwu@live.cn

Chongrui Xu

CONTACT

020-83827812; xuchongrui@gdph.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 13, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

CN (1)