for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Principal Investigator
by Pamela Munster
Headshot of Pamela Munster
Pamela Munster



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


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.


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


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


  • UCSF - Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94115 United States
  • UC Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UCSF

  • Pamela Munster
    Professor, Medicine, School of Medicine. Authored (or co-authored) 141 research publications


accepting new patients
Start Date
Completion Date
Revolution Medicines, Inc.
Phase 1 research study
Study Type
Expecting 108 study participants
Last Updated