A Study of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Ca
This study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-B16D1 in patients with unresectable locally advanced or metastatic breast cancer and other solid tumor.
| Condition(s) | Breast Cancer, Solid Tumor |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary efficacy of BL-B16D1 in patients with unresectable locally advanced or metastatic breast cancer and other solid tumor. |
| Who can participate | Inclusion Criteria: 1. Sign the informed consent form voluntarily and follow the protocol requirements; 2. Gender is not limited; 3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib); 4. Expected survival time ≥3 months; 5. Patients with histologically and/or cytologically confirmed unresectable locally advanced or metastatic breast cancer and other solid tumors who failed or could not receive standard treatment; 6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 3 years; 7. Must have at least one extracranial measurable lesion that meets the RECIST v1.1 definition; 8. ECOG 0 or 1; 9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; 10. No severe |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Sichuan Baili Pharmaceutical Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2024-08-26 |
| NCT ID | NCT06493864 |
| Official listing | https://clinicaltrials.gov/study/NCT06493864 |