Phase 11b Study of IAM1363 in Adults With Advanced Cancers Having HER2 Alterations

What this Trial Is About

Researchers are evaluating IAM1363, an investigational drug, in a Phase 11b open-label study involving participants with advanced cancers that have HER2 alterations. The study aims to assess the safety and early effects of IAM1363 in these patients, including those with brain metastases. This trial includes multiple parts focusing on dose escalation, dose optimization, expansion in specific tumor types, and combination with other anti-cancer treatments. The study has four parts Part 1 involves escalating doses of IAM1363 as a monotherapy to find the maximum tolerated dose. Part 2 optimizes the dose based on safety and preliminary efficacy results. Part 3 expands to tumor-specific groups using the selected dose. Part 4 studies IAM1363 combined with other cancer drugs. Treatments are given orally in 14- or 21-day cycles. Participants will undergo evaluations including monitoring for dose-limiting toxicities, adverse events, and laboratory abnormalities. Researchers will measure responses in tumors and the central nervous system, pharmacokinetics, and treatment modifications. Follow-up will continue through study completion, estimated at about 46 months. Safety is closely monitored during and after treatment, with assessments of heart function and other clinical measures.

A Phase 1/1b Study of IAM1363 in HER2 Cancers