A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
NCT06006169 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 186
Last updated 2025-09-26
Summary
This phase II study is designed to investigate the efficacy and safety of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors.
Conditions
Interventions
- DRUG
-
BL-B01D1
BL-B01D1 was administered by intravenous infusion on D1, D8, or D1 in 3-week cycles.
- DRUG
-
SI-B003
SI-B003 was administered intravenously every 3 weeks (Q3W).
Sponsors & Collaborators
-
Sichuan Baili Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Chaosu Hu · Fudan University
-
Dongmei Ji · Fudan University
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
- 2023-10-20
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- China
Study Locations
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