NCT06469008

A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	BL-B16D1	Administration by intravenous infusion for a cycle of 3 weeks.

Timeline

• Start date: 2024-06-27
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-06-21
• Last updated: 2025-09-18

Locations

1 site across 1 country: China