Clinical Trials /

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

NCT04774952

Description:

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).

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04774952

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: RMC-5552-001
  • NCT ID: NCT04774952

Conditions

  • Solid Tumors

Interventions

DrugSynonymsArms
RMC-5552RMC-5552

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
RMC-5552ExperimentalRMC-5552 for IV administration
  • RMC-5552

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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with adverse events (AEs)
Time Frame:up to 3 years
Safety Issue:
Description: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

Secondary Outcome Measures

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

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Revolution Medicines, Inc.

Trial Keywords

  • PIK3CA
  • PTEN
  • TSC1/2
  • STK11
  • MTOR
  • MYC
  • MAPK
  • advanced solid tumor
  • advanced solid malignancies
  • melanoma
  • skin cancer
  • ovarian cancer
  • endometrium/uterus cancer
  • bladder cancer
  • cervical cancer
  • Carcinoma, Non-Small-Cell Lung
  • Neoplasms, Squamous Cell
  • Carcinoma, Squamous Cell
  • Esophageal Neoplasms
  • Carcinoma, Bronchogenic
  • Bronchial Neoplasms
  • Lung Neoplasms
  • Respiratory Tract Neoplasms
  • Thoracic Neoplasms
  • Neoplasms by Site
  • Neoplasms
  • Lung Diseases
  • Respiratory Tract Diseases
  • Neoplasms, Glandular and Epithelial
  • Gastrointestinal Neoplasms
  • Digestive System Neoplasms
  • Head and Neck Neoplasms
  • Digestive System Diseases
  • Esophageal Diseases
  • Gastrointestinal Diseases
  • 4EBP1

Last Updated

June 18, 2021