Phase 2 Study of IMC-001 Treatment for Adults With Metastatic or Locally Advanced TMB-High Solid Tumors

What this Trial Is About

Researchers are evaluating the effectiveness of IMC-001 in patients with metastatic or locally advanced TMB-High TMB-H solid tumors. This Phase 2 study aims to determine how well IMC-001 works in this specific group of cancer patients, focusing on those with tumors that have a high tumor mutational burden. The trial is sponsored by ImmuneOncia Therapeutics Inc. and seeks to understand the drugs impact on tumor response and patient survival. All participants receive IMC-001 through an intravenous infusion at a dose of 20 mgkg every two weeks, administered over 60 minutes. Treatment can continue for up to 2 years, with each treatment cycle lasting 14 days. Imaging scans to monitor tumor response are performed every 6 weeks during treatment and follow-up, including after the end of treatment. The study includes a safety follow-up visit 28 days after the last dose. Participants will be closely monitored with imaging every 6 weeks to assess tumor changes, progression-free survival, duration of response, and overall survival over an average of one year. Additional assessments include pharmacokinetic and immunogenicity evaluations. The study requires regular visits for treatment, scans, and follow-up, with maximum treatment duration of 2 years. Safety and response data are collected throughout the study period until disease progression or initiation of other treatments.

A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor