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Brief Title: Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors

A Phase 1/1b, Open-Label, Multicenter, Dose-Escalation Study of RMC 5552 Monotherapy in Adult Subjects With Relapsed/Refractory Solid Tumors

INTRODUCTION

  • Org Study ID: RMC-5552-001
  • Secondary ID: N/A
  • NTC ID: NCT04774952
  • 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-5552 monotherapy in adult
participants with relapsed/refractory solid tumors and to identify the recommended Phase 2
dose (RP2D).

DETAILED DESCRIPTION


This is an open-label, multicenter, Phase 1/1b study of RMC-5552 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 mTOR 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
    April 7, 2021
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Number of participants with adverse events (AEs)

Primary Outcome 1 - Timeframe: up to 3 years

Primary Outcome 2 - Measure: Number of participants with dose limiting toxicities (DLTs)

Primary Outcome 2 - Timeframe: 21 days

CONDITION

  • Solid Tumors

ELIGIBILITY


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 stomatitis or mucositis of any grade

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Revolution Medicines, Inc

Role: Study Director

Affiliation: Revolution Medicines, Inc.

Overall Contact

Name: Revolution Medicines, Inc

Phone: (650) 779-2300

Email: CT-Inquiries@RevMed.com

LOCATION

Facility Status Contact
Facility: UC Irvine - Chao Family Comprehensive Cancer Center
Irvine, California 92868
United States
Status: Recruiting Contact:
Oliver Quines, MD
714-456-6244
ucstudy@uci.edu
Facility: Moffitt Cancer Center
Tampa, Florida 33612
United States
Status: Recruiting Contact:
Nevena Ugrenovic
813-745-2025
nevena.ugrenovic@moffitt.org
Facility: University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Status: Recruiting Contact:


Phase1-Referrals@ouhsc.edu
Facility: Sarah Cannon Research Institute - Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United States
Status: Recruiting Contact:

615-339-4214
asksarah@sarahcannon.com