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NCT Number: NCT05379985

Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Adenocarcinoma Advanced Solid Tumors Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Ductal Carcinoma, Non-Small-Cell Lung Carcinoma, Pancreatic Ductal Colonic Diseases Colonic Neoplasms Colorectal Cancer (CRC) Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Melanoma Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplastic Processes Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Pancreatic Diseases Pancreatic Ductal Adenocarcinoma (PDAC) Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UC Irvine/Chao Family Comprehensive Cancer Center, Orange, California, United States

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About this study

This is a Phase 1/2, multicenter open-label study to evaluate the safety, tolerability, pharmacokinetics (PK), and clinical activity of escalating doses of RMC-6236 in adult patients with advanced solid tumors harboring specific RAS mutations, and to determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose [RP2D] within investigated patient population groups. RMC-6236 is a potent, orally bioavailable RAS-MULTI(ON) inhibitor, selective for the active RAS(ON) form of both wild type and mutant variants of the canonical RAS isoforms (HRAS, NRAS, and KRAS).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically confirmed advanced solid tumor with specific KRAS G12 mutations (dose escalation) or RAS mutations (dose optimization/expansion) identified through deoxyribonucleic acid (DNA) sequencing. PDAC with wild-type RAS (expansion).
  • Treatment naive or have received prior standard therapy appropriate for tumor type and stage
  • Have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function

Exclusion criteria

  • Primary central nervous system (CNS) tumors
  • Active, untreated brain metastases
  • Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
  • History of any other unstable or clinically significant concurrent medical condition that would, in the opinion of the investigator, jeopardize the safety of a participant, impact their expected survival through the end of the study participation, and/or impact their ability to comply with the protocol prior/concomitant therapy

Other inclusion/exclusion criteria may apply.

Treatment and study plan

RMC-6236

Drug

Oral Tablets

Primary outcomes

  1. Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs, including incidence and severity of findings in laboratory values and vital signs

    Time frame: up to 2.5 years

  2. Number of Participants with Dose-Limiting Toxicity (DLT)

    Time frame: 21 days

Secondary outcomes

  1. Maximum Observed Blood Concentration (Cmax) of RMC-6236

    Time frame: up to 15 weeks

  2. Time to Reach Maximum Blood Concentration (Tmax) of RMC-6236

    Time frame: up to 15 weeks

  3. Area Under Blood Concentration Time Curve (AUC) of RMC-6236

    Time frame: up to 15 weeks

  4. Elimination Half-Life of RMC-6236 (t1/2)

    Time frame: up to 15 weeks

  5. Ratio of accumulation of RMC-6236 from a single dose to steady state with repeated dosing

    Time frame: up to 15 weeks

  6. Overall Response Rate (ORR)

    Time frame: up to 2.5 years

    Overall response rate per RECIST v1.1

  7. Duration of Response (DOR)

    Time frame: up to 2.5 years

    Duration of response per RECIST v1.1

  8. Disease Control Rate (DCR)

    Time frame: up to 2.5 years

    Disease control rate per RECIST v1.1

  9. Time to Response (TTR)

    Time frame: up to 2.5 years

    Time to response per RECIST v1.1

  10. Progression-Free Survival (PFS)

    Time frame: up to 2.5 years

    Progression-free survival per RECIST v1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Revolution Medicines, Inc.

CONTACT

[email protected]

1-844-273-8633

Sponsors and collaborators

Lead sponsor

Revolution Medicines, Inc.

Industry

Registry information

Official study title

A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 18, 2022
Registry last updated
May 15, 2026

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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