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A Phase Ib/II Study of BM230 in Combination With PD-1 Inhibitor for HER2-related Advanced Solid Tumors

NCT07698587 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-07-13

No results posted yet for this study

Summary

This study is a multicenter, non-randomized, open-label, Phase Ib/II combination therapy trial. The trial consists of two parts: Part 1 (Phase Ib), dose-escalation of combination therapy, followed by Part 2 (Phase II), tumor-type exploration of combination therapy. This study will evaluate the RP2D, safety, tolerability, and preliminary efficacy of BM230 in combination with PD-1 inhibitor in patients with HER2-related solid tumors (including but not limited to colorectal cancer, esophageal squamous cell carcinoma, urothelial carcinoma, cholangiocarcinoma, endometrial cancer, cervical cancer, ovarian cancer, etc.).

Conditions

Interventions

DRUG

BM230 & PD-1 inhibitor

BM230: SC injection; PD-1 inhibitor: IV infusion

DRUG

BM230 & PD-1 inhibitor

BM230: SC injection; PD-1 inhibitor: IV infusion

Sponsors & Collaborators

  • Suzhou Biomissile Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07698587 on ClinicalTrials.gov