A Phase 1/1b, Open-Label, Multicenter, Dose-Escalation Study of RMC-5552 Monotherapy in Adult Subjects 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-5552 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-5552 monotherapy in subjects with relapsed/refractory solid tumors To define the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for RMC-5552 monotherapy in subjects with relapsed/refractory solid tumors Secondary To characterize the plasma pharmacokinetics (PK) of RMC-5552 after single- and repeat-dose administration To evaluate the preliminary antitumor effects of RMC-5552 monotherapy in subjects with relapsed/refractory solid tumors harboring specific genotypic aberrations
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