Phase 1b Study of HC-7366 Combined With Nivolumab, With or Without Ipilimumab, for Advanced Kidney Cancer

What this Trial Is About

Researchers are evaluating the safety and antitumor activity of combining HC-7366 with immunotherapy drugs nivolumab and ipilimumab in adults with advanced clear cell renal cell carcinoma, a type of kidney cancer. This Phase 1b study aims to assess two treatment combinations HC-7366 with nivolumab alone and HC-7366 with both nivolumab and ipilimumab. The study focuses on safety by monitoring serious side effects and measuring tumor response rates using established criteria. Participants receive treatment either as a doublet regimen with HC-7366 taken orally every four weeks alongside intravenous nivolumab, or as a triplet regimen adding intravenous ipilimumab to the same schedule. The study evaluates these combinations for their ability to control cancer progression and also tracks the need for high-dose steroids due to side effects. Both treatment groups allow for close monitoring and adjustment based on response and safety. During the study, participants undergo various scans including bone and brain imaging to monitor disease status. Laboratory tests assess organ function and blood counts before and during treatment. Researchers collect tissue samples for analysis and use questionnaires to evaluate participant-reported health outcomes. The primary outcome is safety over about one year, with secondary outcomes including survival and quality of life measures. Participants remain under observation for disease control and adverse events throughout the study duration.

A Phase 1b Study of HC-7366, an Agonist of ISR With Immunotherapy in Kidney Cancer (SHARK)