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Study of RMC-9805 in Participants With KRASG12D-Mutant Solid Tumors

Revolution Medicines logo

Revolution Medicines

Status and phase

Enrolling
Phase 1

Conditions

Non-small Cell Lung Cancer (NSCLC)
Colorectal Cancer (CRC)
Advanced Solid Tumors
Pancreatic Ductal Adenocarcinoma (PDAC)

Treatments

Drug: RMC-9805

Study type

Interventional

Funder types

Industry

Identifiers

NCT06040541
RMC-9805-001

Details and patient eligibility

About

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

Full 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.

Enrollment

290 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

290 participants in 1 patient group

RMC-9805
Experimental group
Description:
Dose exploration and dose expansion
Treatment:
Drug: RMC-9805

Trial contacts and locations

7

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Central trial contact

Revolution Medicines, Inc.

Data sourced from clinicaltrials.gov

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