OncoMatch/Clinical Trials/NCT06503783
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Negative Breast Cancer and Other Solid Tumors
Is NCT06503783 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-M17D1 for breast cancer.
Treatment: BL-M17D1 — This study is an open, multicenter, dose-escalation and expansion-enrollment nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M17D1 in patients with locally advanced or metastatic HER2 positive/negative breast cancer and other solid tumors.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Tumor Agnostic
Biomarker criteria
Allowed: HER2 (ERBB2) overexpression
HER2-positive/negative breast cancer
Allowed: HER2 (ERBB2) wild-type
HER2-positive/negative breast cancer
Disease stage
Metastatic disease required
locally advanced or metastatic HER2-positive/negative breast cancer and other solid tumors; Must have at least one extracranial measurable lesion that meets the RECIST v1.1 definition
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: not within 4 weeks or 5 half-lives before first dose
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
Exception: not within 4 weeks or 5 half-lives before first dose
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)
Exception: not within 6 weeks before first dose
Mitomycin and nitrosoureas were administered within 6 weeks before the first dose
Cannot have received: nitrosourea (nitrosoureas)
Exception: not within 6 weeks before first dose
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
Exception: prior anthracycline therapy with more than the protocol-specified cumulative dose
Prior anthracycline therapy with more than the protocol-specified cumulative dose of an anthracycline
Lab requirements
Cardiac function
no severe cardiac dysfunction, left ventricular ejection fraction ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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