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BRIEF TITLE: Study of RMC 5552 Monotherapy in Adult Subjects With 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


  • Org Study ID: RMC-5552-001
  • Secondary ID:
  • NCT ID: NCT04774952
  • NCT Alias:
  • Sponsor: Revolution Medicines, Inc. - Industry
  • Source: 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.

Overal Status Start Date Phase Study Type
Recruiting March 2021 Phase 1 Interventional

Primary Outcomes:

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

Primary Outcome 1 - Time Frame: up to 3 years

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

Primary Outcome 2 - Time Frame: 21 days

Condition:

  • Solid Tumors

Eligibility

Criteria:
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
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

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

Locations

Facility Status Contact
UC Irvine - Chao Family Comprehensive Cancer Center
Irvine, California 92868
United States
Not yet recruiting Sai-Hong Ignatius Ou, MD

ucstudy@uci.edu
UC Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Not yet recruiting
UC San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California 94115
United States
Not yet recruiting
Moffitt Cancer Center
Tampa, Florida 33612
United States
Not yet recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10021
United States
Not yet recruiting
University of Oklahoma - Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
United States
Recruiting
Sarah Cannon Research Institute - Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United States
Recruiting
Dell Seton Medical Center at University of Texas
Austin, Texas 78712
United States
Not yet recruiting