Phase 1/1b Multicenter Open-Label Study of RMC-5127 in Patients with Advanced KRAS G12V-Mutant Solid Tumors

Brief description of study

This is a Phase 1/1b study testing RMC-5127 (investigational cancer drug) in adults with advanced solid tumors that have a KRAS G12V mutation, a specific change in cancer cells. RMC-5127 is designed to target cancers that have a KRAS G12V mutation, which is found in some advanced solid tumors such as lung, pancreatic, and colorectal cancers. The study will take place at multiple hospitals or clinics and is open-label, meaning both researchers and participants know which treatment is being given. The goal of the study is to look at how safe RMC-5127 is at different doses, both by itself and when combined with other medicines.

In this study, there are three treatment groups: Arm A , Arm B and Arm C. Each treatment group has two parts: the first part finds a safe dose, and the second part studies how well that dose works in more people. The study will first test RMC-5127 alone (Arm A) to learn about its safety, side effects, how the body processes the drug, and whether it may help shrink tumors. Based on the results from Arm A, researchers may start Arm B (RMC-5127 with daraxonrasib) and Arm C (RMC-5127 with cetuximab) if the treatment appears safe and shows signs of helping patients. The study may also be updated later to test RMC-5127 with other cancer treatments, but any changes must be reviewed and approved by health and ethics committees before they begin.

All patients will have frequent medical check ups to see how their bodies are handling the study medicine. The study team will be monitoring the patients for potential side effects and safety concerns.


Clinical Study Identifier: s25-01364
Principal Investigator: Salman Rafi Punekar.
Other Investigators: David R. Wise, Anam Qureshi, Elaine Shum, Yoke Wah Khoo, Kirby Rodriguez, Manuel Hidalgo Medina, Maya Dimitrova, Eneil De La Pena, Jonathan B Kahn, Janice Mehnert, Joshua K Sabari, Keriann M Scavone, Rajwanth Veluswamy, Paul E. Oberstein, Maria Francis, Douglas K Marks, Elise M Zahriah, Jessica Wang, Michelle Diane Swanson Lightfoot, Carol M Lee, Paige Gugerty, Mariam M Cheaib, Jennifer Chuy, Zujun Li, Rafael Winograd, Elise Roughan, Kristen Spencer, Kathleen M Madden, Nancy Chan, Bhavana Pothuri, Ruth A White, Matthew A. Ingham, Kathleen M Lutz.


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