Brief Title: Dose Escalation of RMC-4630 Monotherapy in Relapsed/Refractory Solid Tumors

INTRODUCTION

• Org Study ID: RMC-4630-01
• Secondary ID: N/A
• NTC ID: NCT03634982
• Sponsor: Revolution Medicines, Inc.

BRIEF SUMMARY

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and
pharmacodynamic (PD) profiles of escalating doses of RMC-4630 monotherapy in adult
participants with relapsed/refractory solid tumors and to identify the recommended Phase 2
dose (RP2D).

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DETAILED DESCRIPTION

This is an open-label, multicenter, Phase 1 study of oral RMC-4630 monotherapy in
participants with advanced relapsed or refractory solid tumors. The study will include 2
components: 1) a Dose-Escalation Component for participants with relapsed or refractory solid
tumors and 2) a Dose-Expansion Component for participants with relapsed or refractory solid
tumors harboring certain specific mutations/rearrangements that result in hyperactivation of
the RAS-MAPK pathway. Participants will be treated until disease progression per RECIST v1.1,
unacceptable toxicity, or other criteria for withdrawal are met, whichever occurs first.

• Overall Status
  Recruiting
• Start Date
  September 28, 2018
• Phase
  Phase 1
• Study Type
  Interventional