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RMC-9805

Phase 1

Non-small Cell Lung Cancer (NSCLC) | Small molecule | Oncology |Revolution Medicines, Inc.|Last Updated: Jun 3, 2026

Target and mechanism

Molecular targetRAS
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment604

FDA Designations

No designations recorded

Clinical trial landscape

RMC-9805 · 1 trial · 4 indications

Phase 1 1
NCT06040541Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid TumorsNon-small Cell Lung Cancer (NSCLC)
RECRUITING604 Analytics
PHASE1RECRUITING
Study of RMC-9805 in Participants With KRAS G12D-Mutant Solid Tumors
Non-small Cell Lung Cancer (NSCLC)Unlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events
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

Dose Limiting Toxicities
21 days

Number of participants with Dose Limiting Toxicities (DLTs)

Secondary Endpoints

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
up to 21 weeks
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
up to 21 weeks
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
up to 21 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RMC-9805 monotherapy armEXPERIMENTALDose exploration and dose expansion
RMC-9805 plus RMC-6236 combination armEXPERIMENTALDose exploration and dose expansion

Interventions

NameTypeDescription
RMC-9805DRUGOral Tablets
RMC-6236DRUGOral Tablets
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

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 ...

Countries:United States
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Frequently asked questions about RMC-9805

What is RMC-9805 used for?

RMC-9805 is an investigational small molecule being developed for the treatment of non-small cell lung cancer (NSCLC). It is also being studied in other KRAS G12D-mutant solid tumors, including colorectal cancer, pancreatic ductal adenocarcinoma, and advanced solid tumors. The drug is currently in Phase 1 clinical development.

What does RMC-9805 target?

RMC-9805 targets RAS, a protein that is frequently mutated in cancer. Specifically, the drug is being studied in patients with KRAS G12D-mutant solid tumors. By targeting RAS, RMC-9805 aims to interfere with cancer cell growth and survival pathways.

Who makes RMC-9805?

RMC-9805 is being developed by Revolution Medicines, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol RVMD. The company is conducting clinical trials to evaluate the safety and efficacy of RMC-9805 in patients with KRAS G12D-mutant solid tumors.

What phase is RMC-9805 in?

RMC-9805 is in Phase 1 clinical development. The drug is investigational and has not been approved by the FDA. It is currently being evaluated in a Phase 1 study to assess its safety, tolerability, and preliminary efficacy in patients with KRAS G12D-mutant solid tumors.

What clinical trials is RMC-9805 in?

RMC-9805 is being studied in a Phase 1 clinical trial with the identifier NCT06040541. This trial is recruiting participants with KRAS G12D-mutant solid tumors, including non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. The study is being conducted in the United States and has an enrollment target of 604 participants.