A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
NCT06469008 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2025-09-18
Summary
This study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerance, pharmacokinetic characteristics and preliminary effectiveness of BL-B16D1 in recurrent or metastatic head and neck squamous cell carcinomas and other solid tumors.
Conditions
- Head and Neck Squamous Cell Carcinomas
- Solid Tumor
Interventions
- DRUG
-
BL-B16D1
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
Principal Investigators
-
Ye Guo · Shanghai East Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-27
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
Countries
- China
Study Locations
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