A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants with Relapsed/Refractory Solid Tumors
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).
Primary: * To characterize the safety and tolerability of RMC-4630 monotherapy in participants with relapsed/refractory solid tumors * To define the MTD, RP2D, and schedule for RMC-4630 monotherapy in participants with relapsed or refractory solid tumors Secondary: * To characterize the plasma PK of RMC-4630 after single- and repeat-dose administration * To characterize the relationship between plasma PK of RMC-4630 and PD * To assess PD markers of drug activity, including biochemical markers of SHP2 inhibition in blood or tumor tissue * To estimate the antitumor effects of RMC-4630 monotherapy at the RP2D in participants with relapsed/refractory solid tumors harboring specific genotypic aberrations in the RAS-MAPK pathway
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