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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06503783 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy, biological therapy, mitomycin 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