The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK),
and pharmacodynamic (PD) profiles of escalating doses of RMC-4630 monotherapy in adult
participants with relapsed/refractory solid tumors and to identify the recommended Phase
2 dose (RP2D).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03634982.
This is an open-label, multicenter, Phase 1 study of oral RMC-4630 monotherapy in
participants with advanced relapsed or refractory solid tumors. The study will include 2
components: 1) a Dose-Escalation Component for participants with relapsed or refractory
solid tumors and 2) a Dose-Expansion Component for participants with relapsed or
refractory solid tumors harboring certain specific mutations/rearrangements that result
in hyperactivation of the RAS-MAPK pathway. Participants will be treated until disease
progression per RECIST v1.1, unacceptable toxicity, or other criteria for withdrawal are
met, whichever occurs first.
Lead OrganizationRevolution Medicines