Phase III Study of Intravenous AMT-253 for Adults With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating AMT-253, an investigational drug, in patients with unresectable or metastatic malignant melanoma and other advanced solid tumors. This is a non-randomized, open-label, multicenter study that includes both Phase I dose escalation and Phase II dose expansion. The study is sponsored by Multitude Therapeutics Inc. and aims to assess safety and response in this patient group. The study involves two treatment arms dose escalation and dose expansion of AMT-253, which is given intravenously. Participants receive this experimental drug according to the assigned dose level or expansion cohort. The study includes both early and later phase components to determine appropriate dosing and evaluate treatment effects over time. Participants will be monitored closely with evaluations including assessment of dose-limiting toxicities during the first 21 days, adverse events, serious adverse events, and overall response rate for up to 24 months. Blood levels of the drug and immune responses will also be measured. Tumor tissue samples are collected at screening, and participants are followed for safety and effectiveness outcomes through scheduled visits during and after treatment.

AMT-253 in Patients With Advanced Solid Tumours