NCT07274852

A Study of Lutetium [177Lu]-BL-ARC001 in Patients With Locally Advanced or Metastatic Lung Cancer, Breast Cancer, 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 Lutetium [177Lu]-BL-ARC001 Injection in Patients With Locally Advanced or Metastatic Lung Cancer, Breast Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open, multicenter, dose-escalation and cohort-expansion non-randomized phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of Lutetium \[177Lu\] BL-ARC001 in patients with locally advanced or metastatic solid tumors.

Detailed description

The study is divided into two stages: the dose-escalation phase (Phase Ia) and the cohort-expansion phase (Phase Ib).

Conditions

• Lung Cancer
• Breast Cancer
• Head and Neck Squamous Cell Carcinoma
• Solid Tumors

Interventions

Type	Name	Description
DRUG	Lutetium [177Lu] BL-ARC001	Administration by intravenous infusion for a cycle of 6 weeks.

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-12-10
• Last updated: 2026-01-06

Locations

1 site across 1 country: China