Ovarian Cancer Clinical Trial

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

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).

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Full 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.

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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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT04774952

Recruitment Status:

Recruiting

Sponsor:

Revolution Medicines, Inc.

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There are 8 Locations for this study

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UC Irvine - Chao Family Comprehensive Cancer Center
Irvine California, 92868, United States More Info
Oliver Quines, MD
Contact
714-456-6244
[email protected]
Kim Inocencio
Contact
(714) 456-8549
[email protected]
Sai-Hong Ignatius Ou, MD
Principal Investigator
UC Davis Comprehensive Cancer Center
Sacramento California, 95817, United States More Info
Anthony Martinez
Contact
916-734-6447
[email protected]
Jonathan Riess, MD
Principal Investigator
UC San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94115, United States More Info
Erika Zigman
Contact
415-885-3728
[email protected]
Swati Sudarsan
Contact
(415) 885-3728
[email protected]
Pamela Munster, MD
Principal Investigator
Moffitt Cancer Center
Tampa Florida, 33612, United States More Info
Nevena Ugrenovic
Contact
813-745-2025
[email protected]
Eric Haura, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10021, United States More Info
Erin Frederickson
Contact
646-888-4888
[email protected]
Alison Schram, MD
Principal Investigator
University of Oklahoma - Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Abdul Naqash, MD
Principal Investigator
Sarah Cannon Research Institute - Tennessee Oncology, PLLC
Nashville Tennessee, 37203, United States More Info
Howard Burris, MD
Principal Investigator
Dell Seton Medical Center at University of Texas
Austin Texas, 78712, United States More Info
Lindsey Simon
Contact
512-495-5419
[email protected]
Anna Capasso, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

108

Study ID:

NCT04774952

Recruitment Status:

Recruiting

Sponsor:


Revolution Medicines, Inc.

How clear is this clinincal trial information?

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