Phase 2 Study to Find the Best Dose and Test Safety of Tinodasertib Alone or With Pembrolizumab or Irinotecan in Treating Metastatic Colorectal Cancer

What this Trial Is About

Researchers are evaluating Tinodasertib, alone or combined with Pembrolizumab or Irinotecan, in patients with locally advanced or metastatic colorectal cancer CRC. This Phase 2 open-label study aims to find the best dose of Tinodasertib and assess its safety, tolerability, and clinical activity when given with these drugs. The study includes patients who have previously received treatment for CRC and focuses on understanding how these combinations work in this patient group. The study is divided into two parts. The first part is a dose escalation phase to find the maximum tolerated dose MTD and recommended Phase 2 dose RP2D of Tinodasertib given orally every other day, alone or with intravenous Pembrolizumab every three weeks or Irinotecan every two weeks. The second part expands on this by treating patients at the RP2D with Tinodasertib plus either Pembrolizumab or Irinotecan to evaluate clinical activity and safety more thoroughly. Participants will undergo regular assessments including monitoring for adverse events, serious side effects, and treatment responses using RECIST criteria. The study will track these outcomes for about two years after enrollment. Additional evaluations include pharmacokinetic studies about six months after enrollment. Patients will provide tumor tissue samples and have their disease measured by imaging. The study includes safety monitoring and follows patients closely throughout their participation.

MNK Inhibitor AUM001 in Combination With Either Pembrolizumab or Irinotecan to Treat Metastatic Colorectal Cancer