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

NCT04774952 | Completed Phase 1 FDA Drug

• 1 other identifier: RMC-5552-001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 8

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).

Conditions

Solid Tumors

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

Outcome Measures

Primary Outcomes (2)

• 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

• Number of participants with dose limiting toxicities (DLTs)

  Incidence and nature of DLTs with RMC-5552 monotherapy

  21 days

Secondary Outcomes (7)

• Cmax

  up to 3 years

• Tmax

  up to 3 years

• Area Under the Curve (AUC)

  up to 3 years

• t1/2

  up to 3 years

• Accumulation Ratio

  up to 3 years

Study Arms (1)

RMC-5552

EXPERIMENTAL

RMC-5552 for IV administration

Drug: RMC-5552

Interventions

RMC-5552 DRUG

RMC-5552 for IV administration

RMC-5552

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• Revolution Medicines, Inc.: lead

Study Sites (8)

UC Irvine - Chao Family Comprehensive Cancer Center

Irvine, California, 92868, United States

Location

UC Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

Location

UC San Francisco - Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

Location

University of Oklahoma - Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Sarah Cannon Research Institute - Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

Dell Seton Medical Center at University of Texas

Austin, Texas, 78712, United States

Location

Related Publications (1)

• Schram AM, Naqash AR, Haura EB, Riess JW, Ulahannan SV, Ou SI, Munster PN, Cheng ML, Gustafson WC, Bitman B, Friedman R, Penn R, Kar S, Seshadri V, Wang Z, Tao L, Yang YC, Singh M, Burris HA, Meyerowitz JG. The Bi-steric, mTORC1-Selective Inhibitor, RMC-5552, in Advanced Solid Tumors: A Phase 1 Trial. Clin Cancer Res. 2025 Dec 1;31(23):4933-4943. doi: 10.1158/1078-0432.CCR-25-2112.

  PMID: 41056387 DERIVED

MeSH Terms

Conditions

Hereditary Sensory and Autonomic Neuropathies; Melanoma; Skin Neoplasms; Ovarian Neoplasms; Uterine Neoplasms; Urinary Bladder Neoplasms; Uterine Cervical Neoplasms; 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

Condition Hierarchy (Ancestors)

Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Uterine Cervical Diseases; Carcinoma; Bronchial Diseases

Study Officials

• Revolution Medicines, Inc

  Revolution Medicines, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: April 7, 2021
• Primary Completion: May 6, 2024
• Study Completion: June 28, 2024
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)