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).
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
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
Participants who have advanced solid tumors that have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments including approved drugs for oncogenic drivers in their tumor type
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Participants in the Dose-Expansion Component must have molecular aberrations in the mTOR pathway
Known or suspected leptomeningeal or brain metastases or spinal cord compression
Primary central nervous system (CNS) tumors
Clinically significant cardiac disease
Active, clinically significant interstitial lung disease or pneumonitis
Subjects with abnormal fasting glucose, type 1 diabetes, or uncontrolled type 2 diabetes are excluded.Subjects with type 2 diabetes with hemoglobin A1C > Subjects with stomatitis or mucositis of any grade
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