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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04774952
• Other study ID #: RMC-5552-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 7, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2024
• Source: Revolution Medicines, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 108
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• RMC-5552
RMC-5552 for IV administration

Locations

Country	Name	City	State
United States	Dell Seton Medical Center at University of Texas	Austin	Texas
United States	UC Irvine - Chao Family Comprehensive Cancer Center	Irvine	California
United States	Sarah Cannon Research Institute - Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of Oklahoma - Stephenson Cancer Center	Oklahoma City	Oklahoma
United States	UC Davis Comprehensive Cancer Center	Sacramento	California
United States	UC San Francisco - Helen Diller Family Comprehensive Cancer Center	San Francisco	California
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Revolution Medicines, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events (AEs)	Incidence, nature, and severity of treatment-emergent AEs and serious AEs, including incidence and severity of findings in laboratory values or vital signs for RMC-5552 monotherapy	up to 3 years
Primary	Number of participants with dose limiting toxicities (DLTs)	Incidence and nature of DLTs with RMC-5552 monotherapy	21 days
Secondary	Cmax	Peak plasma concentration of RMC-5552	up to 3 years
Secondary	Tmax	Time to achieve peak plasma concentration of RMC-5552	up to 3 years
Secondary	Area Under the Curve (AUC)	Area under the plasma concentration time curve of RMC-5552	up to 3 years
Secondary	t1/2	Elimination half-life of RMC-5552	up to 3 years
Secondary	Accumulation Ratio	Ratio of accumulation of RMC-5552 from a single dose to steady state with repeated dosing	up to 3 years
Secondary	Overall Response Rate (ORR)	Overall response rate of RMC-5552 per RECIST v1.1	up to 3 years
Secondary	Duration of Response (DOR)	Duration of response of RMC-5552 per RECIST v1.1	up to 3 years