OncoMatch/Clinical Trials/NCT06493864
A Study of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Is NCT06493864 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-B16D1 for breast cancer.
Treatment: BL-B16D1 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment
who failed or could not receive standard treatment
Cannot have received: chemotherapy
Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose
Cannot have received: biological therapy
Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose
Cannot have received: mitomycin (mitomycin)
Mitomycin and nitrosoureas were administered within 6 weeks before the first dose
Cannot have received: nitrosoureas (nitrosoureas)
Mitomycin and nitrosoureas were administered within 6 weeks before the first dose
Cannot have received: oral antimetabolite (fluorouracil)
Oral drugs such as fluorouracil
Cannot have received: anthracycline (doxorubicin, epirubicin)
Exception: cumulative dose of doxorubicin > 550 mg/m2, epirubicin > 900 mg/m2 or equivalent dose of other similar drugs
In previous (new) adjuvant anthracyclines, the cumulative dose of anthracyclines for doxorubicin > 550 mg/m2, epirubicin > 900 mg/m2 or the equivalent dose of other similar drugs
Lab requirements
Blood counts
The organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulation factor therapy within 14 days before the first dose
Kidney function
Liver function
Cardiac function
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%
No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; The organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulation factor therapy within 14 days before the first dose; Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5ULN; Urinary protein ≤2+ or ≤1000mg/24h
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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