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NCT Number: NCT06040541

Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors

This study is to evaluate the safety and tolerability of RMC-9805 as monotherapy and in combination with RMC-6236 in adults with KRAS G12D-mutant solid tumors.

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Key information

Conditions

Non-small Cell Lung Cancer (NSCLC) Advanced Solid Tumors Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung 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 Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pancreatic Diseases Pancreatic Ductal Adenocarcinoma (PDAC) Pancreatic Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Davis Comprehensive Cancer Center, Sacramento, California, United States

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About this study

This is an open-label, multicenter, Phase 1/1b study of RMC-9805, a selective and orally bioavailable KRAS G12D(ON) inhibitor, in subjects with KRASG12D-mutant solid tumors to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary clinical activity. The study consists of two arms: RMC-9805 monotherapy arm and RMC-9805 plus RMC-6236 combination arm. Both arms consist of two parts: Part 1- dose exploration and Part 2- dose expansion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pathologically documented, locally advanced or metastatic solid tumor with a KRAS G12D-mutation
  • Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage
  • ECOG performance status 0 or 1
  • Adequate organ function

Exclusion criteria

  • Primary central nervous system (CNS) tumors
  • Known or suspected leptomeningeal or active brain metastases or spinal cord compression
  • Known or suspected impairment of gastrointestinal function that may prohibit ability to swallow or absorb an oral medication
  • Participant was previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)

Other inclusion/exclusion criteria may apply.

Treatment and study plan

RMC-9805

Drug

Oral Tablets

RMC-6236

Drug

Oral Tablets

Primary outcomes

  1. Adverse events

    Time frame: Up to 3 years

    Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs

  2. Dose Limiting Toxicities

    Time frame: 21 days

    Number of participants with Dose Limiting Toxicities (DLTs)

Secondary outcomes

  1. Maximum Observed Blood Concentration (Cmax) of RMC-9805 as monotherapy and in combination with RMC-6236, and Cmax of RMC-6236 in combination with RMC-9805

    Time frame: up to 21 weeks

    Cmax

  2. Time to Reach Maximum Blood Concentration (Tmax) of RMC-9805 as monotherapy and in combination with RMC-6236, and Tmax of RMC-6236 in combination with RMC-9805

    Time frame: up to 21 weeks

    Tmax

  3. Area Under Blood Concentration Time Curve (AUC) of RMC-9805 as monotherapy and in combination with RMC-6236, and AUC of RMC-6236 in combination with RMC-9805

    Time frame: up to 21 weeks

    AUC

  4. Ratio of accumulation of RMC-9805 from a single dose to steady state with repeated dosing as monotherapy and in combination with RMC-6236, and ratio of accumulation of RMC-6236 in combination with RMC-9805

    Time frame: up to 21 weeks

    accumulation ratio

  5. Elimination Half-Life (t1/2) of RMC-9805 as monotherapy and in combination with RMC-6236, and t1/2 of RMC-6236 in combination with RMC-9805

    Time frame: up to 21 weeks

    t1/2

  6. Overall Response Rate (ORR)

    Time frame: up to 3 years

    Assess per RECIST v1.1

  7. Duration of Response (DOR)

    Time frame: up to 3 years

    Assess per RECIST v1.1

  8. Disease Control Rate (DCR)

    Time frame: up to 3 years

    Assess per RECIST v1.1

  9. Time to Response (TTR)

    Time frame: up to 3 years

    Assess per RECIST v1.1

  10. Progression-Free Survival (PFS)

    Time frame: up to 3 years

    Assess per RECIST v1.1

Study contacts

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

Revolution Medicines, Inc.

CONTACT

[email protected]

1-844-2-REVMED

Sponsors and collaborators

Lead sponsor

Revolution Medicines, Inc.

Industry

Registry information

Official study title

Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 15, 2023
Registry last updated
Jun 3, 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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