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Completed

NCT Number: NCT04774952

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

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).

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Key information

Conditions

Solid Tumors Adnexal Diseases Bronchial Diseases Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Hereditary Sensory and Autonomic Neuropathies Heredodegenerative Disorders, Nervous System Lung Diseases Lung Neoplasms Male Urogenital Diseases Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Squamous Cell Nervous System Diseases Nervous System Malformations Neurodegenerative Diseases Neuroectodermal Tumors Neuroendocrine Tumors Neuromuscular Diseases Nevi and Melanomas Ovarian Diseases Ovarian Neoplasms Peripheral Nervous System Diseases Polyneuropathies Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UC Irvine - Chao Family Comprehensive Cancer Center, Irvine, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RMC-5552

Drug

RMC-5552 for IV administration

Primary outcomes

  1. 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

  2. Number of participants with dose limiting toxicities (DLTs)

    Time frame: 21 days

    Incidence and nature of DLTs with RMC-5552 monotherapy

Secondary outcomes

  1. Cmax

    Time frame: up to 3 years

    Peak plasma concentration of RMC-5552

  2. Tmax

    Time frame: up to 3 years

    Time to achieve peak plasma concentration of RMC-5552

  3. Area Under the Curve (AUC)

    Time frame: up to 3 years

    Area under the plasma concentration time curve of RMC-5552

  4. t1/2

    Time frame: up to 3 years

    Elimination half-life of RMC-5552

  5. Accumulation Ratio

    Time frame: up to 3 years

    Ratio of accumulation of RMC-5552 from a single dose to steady state with repeated dosing

  6. Overall Response Rate (ORR)

    Time frame: up to 3 years

    Overall response rate of RMC-5552 per RECIST v1.1

  7. Duration of Response (DOR)

    Time frame: up to 3 years

    Duration of response of RMC-5552 per RECIST v1.1

Sponsors and collaborators

Lead sponsor

Revolution Medicines, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 1, 2021
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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