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

• ClinicalTrials.gov Identifier: NCT04774952
• Recruitment Status: Active, not recruiting
• First Posted: March 1, 2021
• Last Update Posted: February 20, 2024
• Sponsor: Revolution Medicines, Inc.
• Information provided by (Responsible Party): Revolution Medicines, Inc.

Tracking Information

• First Submitted Date: February 25, 2021
• First Posted Date: March 1, 2021
• Last Update Posted Date: February 20, 2024
• Actual Study Start Date: April 7, 2021
• Estimated Primary Completion Date: March 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 25, 2021)

• Number of participants with adverse events (AEs) [ Time Frame: up to 3 years ]
  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
• Number of participants with dose limiting toxicities (DLTs) [ Time Frame: 21 days ]
  Incidence and nature of DLTs with RMC-5552 monotherapy

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 25, 2021)

• Cmax [ Time Frame: up to 3 years ]
  Peak plasma concentration of RMC-5552
• Tmax [ Time Frame: up to 3 years ]
  Time to achieve peak plasma concentration of RMC-5552
• Area Under the Curve (AUC) [ Time Frame: up to 3 years ]
  Area under the plasma concentration time curve of RMC-5552
• t1/2 [ Time Frame: up to 3 years ]
  Elimination half-life of RMC-5552
• Accumulation Ratio [ Time Frame: up to 3 years ]
  Ratio of accumulation of RMC-5552 from a single dose to steady state with repeated dosing
• Overall Response Rate (ORR) [ Time Frame: up to 3 years ]
  Overall response rate of RMC-5552 per RECIST v1.1
• Duration of Response (DOR) [ Time Frame: up to 3 years ]
  Duration of response of RMC-5552 per RECIST v1.1

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dose Escalation of RMC-5552 Monotherapy in Relapsed/Refractory Solid Tumors
• Official Title: A Phase 1/1b, Open-Label, Multicenter, Dose-Escalation Study of RMC 5552 Monotherapy in Adult Subjects With Relapsed/Refractory Solid Tumors
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Solid Tumors

Intervention

Drug: RMC-5552

RMC-5552 for IV administration

Study Arms

Experimental: RMC-5552

RMC-5552 for IV administration

Intervention: Drug: RMC-5552

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: February 25, 2021): 108
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2024
• Estimated Primary Completion Date: March 31, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04774952
• Other Study ID Numbers: RMC-5552-001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Revolution Medicines, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Revolution Medicines, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Revolution Medicines, Inc; Revolution Medicines, Inc.

• PRS Account: Revolution Medicines, Inc.
• Verification Date: February 2024