OncoMatch/Clinical Trials/NCT05470348
A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Is NCT05470348 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-B01D1 for breast cancer.
Treatment: BL-B01D1 — In this study, the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), recommended phase II dose (RP2D), the preliminary efficacy, pharmacokinetic characteristics, and immunogenicity of BL-B01D1 will be investigated in patients with unresectable locally advanced or metastatic breast cancer and other solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic therapy
Exception: triple-negative breast cancer (unresectable locally advanced or recurrent/metastatic) must be treatment-naive
Enrolled subjects should not have received prior systemic therapy for unresectable locally advanced or recurrent/metastatic triple-negative breast cancer
Cannot have received: biological therapy
Received biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose
Cannot have received: immunotherapy
Received biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose
Cannot have received: antitumor treatment
Received biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose (6 weeks for mitomycin and nitrosoureas; oral fluorouracil drugs such as tegafur/gimeracil/oteracil (S-1) or capecitabine, or oral endocrine therapy, or palliative radiotherapy within 2 weeks before the first dose)
Cannot have received: anthracycline
Exception: cumulative dose >360 mg/m² in prior (neo)adjuvant anthracycline therapy
Cumulative anthracycline dose >360 mg/m² in prior (neo)adjuvant anthracycline therapy
Lab requirements
Blood counts
Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0
Kidney function
Liver function
Cardiac function
No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%
Organ function levels must meet the requirements without transfusion or use of any cell growth factors and/or platelet-raising drugs within 14 days before the first dose of the study drug; No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%; Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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