Study of BM230 in Patients With Advanced Solid Tumors
NCT06644300 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 123
Last updated 2026-01-29
Summary
This study is a Phase I, multicenter, non-randomized, open-label, first-in-human study of BM230 conducted globally. The study will include two parts: a dose escalation part (Phase Ia) followed by a dose expansion part (Phase Ib). Phase Ia part will estimate the MTD/RED(s) in dose escalation cohorts of patients with advanced solid tumors (HER2-related solid tumors). The Phase Ib part will enroll 5 distinct cohorts of patients with advanced solid tumors related to HER2 under MTD/RED doses, to better define the safety profile of BM230 and evaluate the efficacy of BM230.
Conditions
Interventions
- DRUG
-
BM230
SC injection
- DRUG
-
BM230
SC injection
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
- 2024-12-16
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- Australia
- China
Study Locations
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