OncoMatch/Clinical Trials/NCT06500052
A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors
Is NCT06500052 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies BL-M17D1 for esophageal 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 locally advanced or metastatic HER2 positive/lower expression gastrointestinal cancer and other solid tumors.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Esophageal Carcinoma
Gastric Cancer
Pancreatic Cancer
Colorectal Cancer
Tumor Agnostic
Biomarker criteria
Required: HER2 (ERBB2) overexpression (positive HER2 / low expression)
locally advanced or metastatic positive HER2 / low expression of the digestive tract tumor and other solid tumor
Disease stage
Metastatic disease required
locally advanced or metastatic positive HER2 / low expression of the digestive tract tumor and other solid tumor; Must have at least one measurable lesion according to RECIST v1.1 definition
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: chemotherapy or biological therapy
Anti-tumor therapy such as chemotherapy or biological therapy has 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: antimetabolite (fluorouracil)
Oral drugs such as fluorouracil
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 NCT06500052 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior chemotherapy or biological therapy, mitomycin, nitrosoureas disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for 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 qualify