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



Status:Recruiting
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/27/2019
Start Date:September 28, 2018
End Date:October 1, 2021
Contact:Revolution Medicines, Inc.
Email:CT-Inquiries@RevolutionMedicines.com
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
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
We found this trial at
9
sites
10510 North 92nd Street
Scottsdale, Arizona 85251
Principal Investigator: Michael Gordon, MD
Phone: 480-323-1791
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Aurora, Colorado 80045
Principal Investigator: Jose Pacheco, MD
Phone: 720-848-0667
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Pasi Janne, MD, PhD
Phone: 617-632-3383
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Duarte, California 91010
Principal Investigator: Marianna Koczywas, MD
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Nashville, Tennessee 37203
Principal Investigator: Howard Burris, III, MD
Phone: 877-691-7274
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Oklahoma City, Oklahoma 73104
Principal Investigator: Susanna Ulahannan, MD
Phone: 405-271-8778
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Oklahoma City, OK
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101 The City Drive South
Orange, California 92868
Principal Investigator: Sai-Hong Ignatius Ou, MD, PhD
Phone: 877-824-3627
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Orange, CA
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Sarasota, Florida 34232
Principal Investigator: Judy Wang, MD
Phone: 941-377-9993
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Sarasota, FL
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Tampa, Florida 33612
Principal Investigator: Eric Haura, MD
Phone: 813-745-6636
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Tampa, FL
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