NCT06644300

Study of BM230 in Patients With Advanced Solid Tumors

A Phase I, Multicenter, Non-randomized, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BM230 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 123 (estimated)
• Sponsor: Suzhou Biomissile Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Solid Tumor

Interventions

Type	Name	Description
DRUG	BM230	SC injection
DRUG	BM230	SC injection

Timeline

• Start date: 2024-12-16
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2024-10-16
• Last updated: 2026-01-29

Locations

6 sites across 2 countries: Australia, China