Phase 12 Study Evaluating Safety and Tolerability of CT7439 Alone and with Other Cancer Treatments in Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are studying CT7439, an experimental drug, in adults with locally advanced or metastatic solid cancers to assess its safety and tolerability. This Phase 12, modular, multi-part study focuses on first-in-human dose escalation to find the appropriate doses when given alone or combined with other anticancer treatments. The study aims to identify the minimum biologically active dose and maximum tolerated or feasible dose of CT7439. Participants will receive CT7439 capsules by mouth once daily, starting with a single 1 mg dose followed by a treatment-free period before continuous dosing in 28-day cycles. Dose escalation cohorts will be sequentially evaluated, with up to six cohorts planned. Participants will continue treatment until disease progression, unacceptable side effects, withdrawal, or study completion. Further cohorts may be added to explore specific patient subgroups. During the study, participants will undergo regular safety and health assessments, including monitoring of vital signs, blood tests, ECGs, and tumor imaging using CT or MRI. Researchers will track treatment side effects and measure drug levels in the blood and urine. The study includes monitoring from the first dose through multiple 28-day cycles, with follow-up visits after treatment ends to evaluate overall response, progression-free survival, and other safety outcomes.

A Modular Phase 1/2 Study With CT7439 in Participants With Solid Malignancies