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

Sponsor
Suzhou Biomissile Pharmaceuticals Co., Ltd.
Study ID
NCT07698587
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Solid Tumor

Eligibility Criteria

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

Interventions

  • BM230 & PD-1 inhibitor — DRUG
    BM230: SC injection; PD-1 inhibitor: IV infusion
  • BM230 & PD-1 inhibitor — DRUG
    BM230: SC injection; PD-1 inhibitor: IV infusion

Study Details

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.).

Key Dates

First listed
Jul 13, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: BM230 combined with PD-1 inhibitor: Dose Escalation
    Drug:BM230 Drug:Tislelizumab Injection
  • Experimental: BM230 combined with PD-1 inhibitor: Tumor Exploration
    Drug:BM230 Drug:Tislelizumab Injection

Primary Outcome Measure

DLT [ Time Frame: 21 days ]

Central Contacts

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