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

Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:September 28, 2018
End Date:October 1, 2021
Contact:Revolution Medicines, Inc.
Phone:(650) 779-2300

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A Phase 1, Open-Label, Multicenter, Dose-Escalation Study of RMC-4630 Monotherapy in Adult Participants 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-4630 monotherapy in adult
participants with relapsed/refractory solid tumors and to identify the recommended Phase 2
dose (RP2D).

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.

Inclusion Criteria:

- Participant (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 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

- 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
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