Actively Recruiting
Phase 1 Study of IM-1617 to Test Safety and Effectiveness in Adults With Advanced Solid Tumors
Led by Immunome, Inc. · Updated on 2026-07-09
175
Participants Needed
2
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of a drug called IM-1617 in participants with unresectable locally advanced or metastatic solid tumors. This Phase 1, open-label, multicenter study includes participants with advanced cancers such as colorectal cancer, non-small cell lung cancer, breast cancer, esophageal cancer, and stomach cancer. The study aims to find a safe dose and schedule for IM-1617 and assess its effects in specific cancer groups. The study has two parts. Part A involves dose escalation to determine the recommended dose for expansion by testing increasing doses of IM-1617 given intravenously. Part B uses the dose found in Part A to further study the safety and preliminary effectiveness of IM-1617 monotherapy in up to four cancer-specific groups. Approximately 75 participants will enroll in Part A, and about 100 in Part B. Participants will receive IM-1617 through intravenous infusions and be monitored for adverse events, pharmacokinetics, and antitumor activity for up to about 12 months. Researchers will assess safety by tracking side effects and serious events after dosing and measure tumor response using standard criteria. This study includes regular evaluations during and after treatment to monitor health and drug effects.
CONDITIONS
Brief Title
A Phase 1 Study of IM-1617 in Participants With Advanced Cancer
Research Team
I
Immunome Medical Monitor
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