NCT06471205 A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer
| NCT ID | NCT06471205 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Sichuan Baili Pharmaceutical Co., Ltd. |
| Condition | Triple-negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2024-08-02 |
| Primary Completion | 2026-07 |
Trial Parameters
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Brief Summary
This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.
Eligibility Criteria
Inclusion Criteria: 1. Voluntarily sign the informed consent and follow the requirements of the protocol; 2. Age: ≥18 years old and ≤75 years old; 3. Expected survival time ≥3 months; 4. ECOG 0 or 1; 5. Subjects with histologically and/or cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer; 6. Patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer; 7. A archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided; 8. Must have at least one place in accordance with RECIST v1.1 define measurable lesions; 9. No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements; 10. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
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