This phase 1b/2 trial will investigate the safety of RMC-4630 and cobimetinib (Cotellic) in relapsed or unresponsive solid tumors.
The main outcomes will be the number of side effects and the overall response rate. This trial is recruiting in a number of US states.
Relapsed/refractory (R/R) cancer is a term for cancer that comes back after or does not respond to standard treatments. R/R cancer is difficult to treat. Newer drugs target specific genes or proteins. They may be more successful in treating R/R cancers. RMC-4630 is an experimental drug. It targets an enzyme called SHP2. Cobimetinib is a drug approved to treat melanoma. It targets a protein called MEK. Cobimetinib is suitable for patients with MEK-positive cancers.
This trial will investigate the safety of RMC-4630 and cobimetinib in R/R tumors. The main outcomes will be the number of side effects and tumor response.
Who are they looking for?
This trial will recruit 144 participants with tumors that do not respond to standard anti-cancer therapy. The tumor must have mutations (abnormalities) or extra copies of the following genes: KRAS, BRAF, or NF1 LOF. Participants must have adequate bone marrow, kidney, and liver function. Contraception must be used during the trial to prevent pregnancy.
Patients cannot take part in the trial if they have brain or spinal cord tumors. Patients with significant heart, eye or lung disease cannot take part. Other exclusion criteria are active infection including HIV, hepatitis B, and C. Any other unstable disease that might impact patient survival is also excluded. Pregnant and breastfeeding women cannot take part in the trial.
How will it work
All patients will be treated with RMC-4630 and cobimetinib. Both drugs are taken orally. Patients will be assigned to different doses in the first phase. In the second phase, all patients will be assigned to the same dose of RMC-4630. Patients can continue on treatment for up to 3 years.
The main outcomes will be the number of side effects and response to treatment for up to 3 years.