Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors

Summary

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).

Timeline

Start

2021-04-07

Primary completion

2024-05-06

Completion

2024-06-28

Publications

• Schram AM, Naqash AR, Haura EB, Riess JW, Ulahannan SV, Ou SI, Munster PN, Cheng ML, Gustafson WC, Bitman B, Friedman R, Penn R, Kar S, Seshadri V, Wang Z, Tao L, Yang YC, Singh M, Burris HA, Meyerowitz JG. The Bi-steric, mTORC1-Selective Inhibitor, RMC-5552, in Advanced Solid Tumors: A Phase 1 Trial. Clin Cancer Res. 2025 Dec 1;31(23):4933-4943. doi: 10.1158/1078-0432.CCR-25-2112.

Drugs

Indications