A Study of BL-M09D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors
NCT06954077 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2025-05-31
Summary
This study is an open, multicenter, dose-escalation and expanded-enrollment, nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M09D1 for injection in patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors.
Conditions
- Gastrointestinal Tumor
- Solid Tumor
Interventions
- DRUG
-
BL-M09D1
Administration by intravenous infusion for a cycle of 3 weeks.
Sponsors & Collaborators
-
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
collaborator INDUSTRY -
Sichuan Baili Pharmaceutical Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-15
- Primary Completion
- 2027-05-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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