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Clinical Trial 21129

Cancer Type: Multiple
Study Type: Treatment
NCT#: NCT04774952

Phase: Phase I
Principal Investigator: Haura, Eric

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Study Title

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



Therapy (NOS)


RMC-5552 ()

Inclusion Criteria

  • Participants (male or female) >;18 years of age
  • 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
  • Adequate hematologic, hepatic and renal function

  • Exclusion Criteria

  • 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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