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 (Jun 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
Treatments studied
Other
Cancer type
Breast Carcinoma
Tumor Agnostic
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT05470348 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic therapy, biological therapy, immunotherapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages