NCT07232524

A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M24D1 for Injection in Patients With Locally Advanced or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open, multicenter, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M24D1 in patients with locally advanced or metastatic head and neck squamous cell carcinoma and other solid tumors.

Detailed description

The study is divided into two phases: a dose escalation phase (Phase Ia) and a dose expansion phase (Phase Ib).

Conditions

• Head and Neck Squamous Cell Carcinoma
• Solid Tumor

Interventions

Type	Name	Description
DRUG	BL-M24D1	Administration by intravenous infusion for a cycle of 2 weeks.

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-11-18
• Last updated: 2025-12-31

Locations

1 site across 1 country: China