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Clinical Trial 19683

Cancer Type: Thoracic
Interventions:RMC-4630

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Eric Haura

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants with Relapsed/Refractory Solid Tumors

Summary

Objective

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

Inclusion Criteria

  • Male or female, 18 years of age or older.
  • 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 one of the following genotypic aberrations: RTK mutations, amplifications or rearrangements, KRASG12, BRAF Class 3, or NF1 LOF mutations
  • Adequate hematologic, hepatic and renal function
  • Participant able to understand and voluntarily sign the informed consent form (ICF) and able to comply with the study visit schedule and other protocol requirements.
  • Participants willing to agree to not father a child/become pregnant and comply with effective contraception criteria

  • 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
  • History or current evidence of retinal pigment epithelial detachment (RPED), central serous retinopathy, retinal vein occlusion (RVO), or predisposing factors to RPED or RVO
  • Known HIV infection
  • Active/chronic hepatitis B or C infection
  • Any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy
  • Females who are pregnant or breastfeeding