Phase III Study of AMT-676, an Anti-CDH17 Antibody-Drug Conjugate, for Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are conducting a first-in-human, open-label, multicenter Phase IaIb study to evaluate AMT-676, an antibody-drug conjugate targeting CDH17, in patients with advanced solid tumors. This early-phase trial aims to determine the recommended dose for further studies and assess safety, tolerability, and preliminary efficacy in patients whose cancers have progressed after standard treatments. The study is sponsored by Multitude Therapeutics Inc. Participants will receive AMT-676 through intravenous infusion. The study includes dose escalation to identify the maximum tolerated dose and recommended Phase 2 dose. During treatment, patients will be monitored for dose-limiting toxicities and adverse events. The study period involves treatment administration and follow-up lasting at least 30 days after the last dose to assess safety and drug behavior. Throughout the trial, participants will undergo regular assessments including tumor measurements based on RECIST criteria, laboratory tests for organ function, and monitoring for adverse effects. Researchers will measure key outcomes such as dose recommendations, safety profiles, drug concentration in blood, immune response against the drug, and clinical response of tumors. The study requires patients to have measurable disease and adequate health status to participate, with ongoing evaluation during and after treatment to ensure safety and collect comprehensive data.

AMT-676 in Patients With Advanced Solid Tumors