RecruitingPhase 1NCT06500052

A Study of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M17D1 in Patients With Locally Advanced or Metastatic HER2 Positive/Lower Expression Gastrointestinal Cancer and Other Solid Tumors


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

20 participants

Start Date

Jul 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new antibody-drug conjugate called BL-M17D1 — a targeted therapy that delivers chemotherapy directly to cancer cells with HER2 protein on their surface — in patients with advanced gastrointestinal cancers and other solid tumors. **You may be eligible if...** - You are 18 or older (up to 75 for the first phase) with confirmed advanced or metastatic gastrointestinal cancer or other solid tumor that has HER2 expression (positive or low levels) - Your expected survival is at least 3 months - You have at least one measurable tumor and are willing to provide a tissue sample - Your general health score and organ function are adequate **You may NOT be eligible if...** - Your tumor has no HER2 expression - You have active brain metastases, serious lung inflammation, or uncontrolled infections - You have had prior treatments that specifically disqualify you - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-M17D1

Administration by intravenous infusion for a cycle of 3 weeks.


Locations(1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

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NCT06500052


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