A Phase I Study of BL-M24D1 Given by Intravenous Infusion to Evaluate Safety, Drug Behavior, and Early Effects in Adults With Advanced or Metastatic Gastrointestinal and Other Solid Tumors

What this Trial Is About

Researchers are evaluating BL-M24D1 in an open, multicenter, non-randomized Phase I clinical trial for patients with locally advanced or metastatic gastrointestinal tumors and other solid tumors. The study aims to assess the safety, tolerability, pharmacokinetics, and preliminary effectiveness of this drug. This research is sponsored by Sichuan Baili Pharmaceutical Co., Ltd. and includes two phases a dose escalation phase Phase Ia and a cohort expansion phase Phase Ib. Participants receive BL-M24D1 through intravenous infusion over a two-week cycle. Those who show clinical benefit may continue treatment for additional cycles. Treatment continues until disease progression, intolerable side effects, or other reasons cause termination. The study monitors dose limiting toxicity, maximum tolerated dose, and recommends a phase II dose during Phase Ia and Ib respectively. Throughout the study, participants will undergo regular assessments including safety monitoring for adverse events and pharmacokinetic evaluations such as drug concentration and clearance. Tumor responses will also be measured, including objective response rate and duration of response. This monitoring may continue for up to 24 months. Participants must meet specific health and tumor criteria before joining and will be closely observed for any treatment effects during the trial period.

A Study of BL-M24D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors