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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 (May 2026). This Phase 1 trial studies BL-M17D1 for esophageal cancer.

Phase 1RecruitingSichuan Baili Pharmaceutical Co., Ltd.NCT06500052Data as of May 2026

Treatment: BL-M17D1This 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.

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Extracted eligibility criteria

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)

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.

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