Phase I Study of Lutetium 177Lu BL-ARC001 Injection for Safety and Preliminary Effectiveness in Patients With Advanced or Metastatic Gastrointestinal and Other Solid Tumors

What this Trial Is About

Researchers are evaluating Lutetium 177Lu BL-ARC001 in a Phase I clinical trial focusing on patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of this investigational drug. It is conducted as an open-label, multicenter, non-randomized trial sponsored by Sichuan Baili Pharmaceutical Co., Ltd. The trial consists of two phases a dose escalation phase Phase Ia and a cohort expansion phase Phase Ib. Participants receive Lutetium 177Lu BL-ARC001 through intravenous infusion over a 6-week cycle. Those who experience clinical benefit may continue with additional treatment cycles. Treatment will stop if disease progression, intolerable side effects, or other reasons occur. Participants will be monitored for up to approximately 24 months to evaluate various outcomes, including dose-limiting toxicity, maximum tolerated dose, recommended Phase II dose, and treatment-emergent adverse events. The study also measures pharmacokinetic parameters such as Cmax, Tmax, half-life, and clearance, along with antibody response and radiation characteristics. Tumor response rates and duration of response are tracked to assess preliminary efficacy.

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