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

a study on Solid Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Sai-Hong Ignatius Ou, MD

Description

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).

Official Title

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

Details

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.

Keywords

Solid Tumors 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 RMC-5552

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UC Irvine - Chao Family Comprehensive Cancer Center accepting new patients
    Irvine California 92868 United States
  • UC San Francisco - Helen Diller Family Comprehensive Cancer Center not yet accepting patients
    San Francisco California 94115 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Revolution Medicines, Inc.
ID
NCT04774952
Phase
Phase 1
Study Type
Interventional
Last Updated
Contact us about this trial