Part 1 is a Phase 1a, first-in-human, open-label dose-escalation study to determine the safety, tolerability, and maximum tolerated dose (MTD) of IMGS-001. The safety, tolerability, PK parameters, and preliminary antitumor activity of IMGS-001 will be assessed in adult patients with advanced solid tumors refractory to appropriate standard of care (SOC) treatments.
Based on the MTD and other information (e.g., tolerability, PK, PD, target engagement), two doses of IMGS-001 will be selected for further evaluation. Additional subjects will be backfilled until at least 10 evaluable subjects have been treated with each of these doses. Approximately 25 total subjects will be enrolled in Phase 1a.
Part 2 is a Phase 1b, open-label, dose-expansion study of five prespecified tumor cohorts to assess preliminary antitumor activity of IMGS-001 in patients that are refractory or intolerant to other appropriate prior standard therapies. Eligible patients must have confirmed PD-L1 expression. To meet PD-L1 expression eligibility in Phase 1b, patients must have confirmed PD-L1 expression (combined positive score (CPS) ≥ 5 or tumor proportion score (TPS) ≥ 5%). Initially, up to 10 subjects in each of the following cohorts will be treated:
Cohort 1: Ovarian cancer; Cohort 2: Colorectal cancer; Cohort 3: Triple-negative breast cancer; Cohort 4: Bladder cancer; Cohort 5: Gastric or esophageal cancer (gastroesophageal junction (GEJ) or esophageal adenocarcinoma).
Each cohort will be assessed to meet efficacy criteria to continue into a randomized dose-optimization. Within each cohort that meets prespecified efficacy criteria, the expanded cohorts will have randomly assigned (1:1) subjects to receive one of two doses used in the Phase 1a. Within each Arm, 20 eligible subjects will be treated with the assigned dose of IMGS-001.
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
