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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06040541
Other study ID # RMC-9805-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 7, 2023
Est. completion date July 31, 2026

Study information

Verified date September 2023
Source Revolution Medicines, Inc.
Contact Revolution Medicines, Inc.
Phone (650) 779-2300
Email CT-inquiries@RevMed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

This is an open-label, multicenter, Phase 1/1b study of RMC-9805, monotherapy, 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 parts: Part 1- Dose-Exploration and Part 2- Dose-Expansion.


Recruitment information / eligibility

Status Recruiting
Enrollment 290
Est. completion date July 31, 2026
Est. primary completion date August 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Pathologically documented, locally advanced or metastatic solid tumor malignancy with KRASG12D-mutations identified through deoxyribonucleic acid (DNA) sequencing or polymerase chain reaction (PCR) test - 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 KRASG12D inhibitor or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors) Other inclusion/exclusion criteria may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
RMC-9805
Oral Tablets

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts
United States The Christ Hospital Cincinnati Ohio
United States Mary Crowley Cancer Research Dallas Texas
United States NEXT Oncology Virginia Fairfax Virginia
United States University of Texas, MD Anderson Cancer Center Houston Texas
United States Carolina BioOncology Institute Huntersville North Carolina
United States START San Antonio Texas

Sponsors (1)

Lead Sponsor Collaborator
Revolution Medicines, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs and clinically significant changes in laboratory values, ECGs, and vital signs Up to 3 years
Primary Dose Limiting Toxicities Number of participants with Dose Limiting Toxicities (DLTs) 21 days
Secondary Maximum Observed Blood Concentration (Cmax) of RMC-9805 Cmax up to 21 weeks
Secondary Time to Reach Maximum Blood Concentration (Tmax) of RMC-9805 Tmax up to 21 weeks
Secondary Area Under Blood Concentration Time Curve (AUC) of RMC-9805 AUC up to 21 weeks
Secondary Ratio of accumulation of RMC-9805 from a single dose to steady state with repeated dosing accumulation ratio of RMC-9805 up to 21 weeks
Secondary Elimination Half-Life (t1/2) of RMC-9805 t1/2 up to 21 weeks
Secondary Overall Response Rate (ORR) Assess per RECIST v1.1 up to 3 years
Secondary Duration of Response (DOR) Assess per RECIST v1.1 up to 3 years
Secondary Disease Control Rate (DCR) Assess per RECIST v1.1 up to 3 years
Secondary Time to Response (TTR) Assess per RECIST v1.1 up to 3 years
Secondary Progression-Free Survival (PFS) Assess per RECIST v1.1 up to 3 years
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