NCT07232407

A Study of Lutetium [177Lu] BL-ARC001 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Lutetium [177Lu] BL-ARC001 Injection in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors 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-label, multicenter, non-randomized Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic profile, 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 phases: a dose escalation phase (Phase Ia) and a cohort expansion phase (Phase Ib).

Conditions

• Gastrointestinal Tumors
• Solid Tumors

Interventions

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

Timeline

• Start date: 2025-11-14
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-11-18
• Last updated: 2026-01-07

Locations

1 site across 1 country: China