Study of BM230 in Patients With Advanced Solid Tumors
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 adv
| Condition(s) | Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: Common inclusion criteria (Phase Ia and Phase Ib) (Criteria 1 to 9) Patients must satisfy all the following criteria to be included in the study: 1. Informed of the study before any study-specific procedures are undertaken and voluntarily sign their name and date on the informed consent form (ICF) 2. Males and Females≥18 years old（at the time consent is obtained） 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 2 4. Life expectancy of ≥ 3 months 5. Adequate organ and bone marrow function, defined as: * Bone marrow function: hemoglobin ≥ 90 g/L (have not received blood transfusion or erythropoietin treatment within 14 days before the first dose); absolute neutrophil count ≥ 1.5×109/L (have not received granulocyte colony-stimulating factor |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Suzhou Biomissile Pharmaceuticals Co., Ltd. |
| Locations | Brisbane, Queensland, Australia; Adelaide, South Australia, Australia; Monash, Victoria, Australia; Bengbu, Anhui, China; Shanghai, Shanghai Municipality, China; Hangzhou, Zhejiang, China |
| Start date | 2024-12-16 |
| NCT ID | NCT06644300 |
| Official listing | https://clinicaltrials.gov/study/NCT06644300 |