The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK),
and pharmacodynamic (PD) profiles of escalating doses of RMC-5552 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 NCT04774952.
This is an open-label, multicenter, Phase 1/1b study of RMC-5552 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 mTOR 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
