What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC), particularly those targeting KRAS mutations like sotorasib and adagrasib, often result in side effects such as liver function test abnormalities, diarrhea, anemia, hepatitis, and hyponatremia. Chemotherapy agents like docetaxel and cisplatin can cause fatigue, nausea, increased risk of infection, and hematologic toxicities. Immune checkpoint inhibitors may lead to immune-related adverse events including pneumonitis, colitis, and endocrinopathies.

What prior FDA approvals exist?

For the treatment of Non-Small Cell Lung Cancer (NSCLC), the FDA has approved several targeted therapies. Notably, for KRAS mutations, the FDA approved sotorasib (Lumakras) for KRAS G12C-mutant NSCLC. Additionally, for other genetic alterations in NSCLC, the FDA has approved selpercatinib and pralsetinib for RET fusion-positive NSCLC, and fam-trastuzumab deruxtecan for HER2-mutant NSCLC. These approvals highlight the ongoing efforts to target specific genetic mutations in NSCLC, similar to the investigational KRAS G12D inhibitor RMC-9805.

What other types of research exist?

Promising novel alternatives to RMC-9805 for NSCLC patients include selpercatinib, a potent RET inhibitor with demonstrated efficacy and tolerability in RET fusion-positive NSCLC, and pralsetinib, another selective RET inhibitor showing clinical activity in RET fusion-positive solid tumors. Both agents have shown significant antitumor activity and are well-tolerated, making them viable options for treatment in 2024.

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Monoclonal Antibodies

RMC-9805 for Solid Cancers

Phase 1

Recruiting

Research Sponsored by Revolution Medicines, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status 0 or 1

Pathologically documented, locally advanced or metastatic solid tumor malignancy with KRASG12D-mutations identified through DNA sequencing or PCR test

Must not have

Participant was previously treated with an investigational KRASG12D inhibitor or had prior therapy with any direct RAS-targeted therapy (eg, degraders and inhibitors)

Known or suspected leptomeningeal or active brain metastases or spinal cord compression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new oral drug, RMC-9805, in adults with a specific type of cancer mutation (KRAS G12D). The drug aims to block a faulty gene to potentially stop cancer growth.

Who is the study for?

This trial is for adults with advanced solid tumors that have a specific mutation called KRAS G12D. Participants must have tried standard treatments without success or could not tolerate them, and should be in fairly good health (ECOG status 0 or 1) with their organs working well. People can't join if they have issues absorbing pills, brain tumors, active brain metastases, spinal cord compression, or previous treatment with similar investigational drugs.

What is being tested?

The study tests the safety and how well people can handle RMC-9805 in those who have certain types of cancer like lung, colorectal, pancreatic cancer etc., all of which share the KRAS G12D mutation. The main goal is to see what happens when patients take this new drug.

What are the potential side effects?

While the side effects are being studied as part of this trial's purpose and aren't fully known yet, potential risks may include typical reactions to cancer medications such as nausea, fatigue, liver problems among others depending on individual patient response.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer is advanced or has spread, and tests show a KRASG12D mutation.

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My cancer has worsened or I couldn't tolerate the standard treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with drugs targeting the KRASG12D mutation or similar.

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I have or might have cancer spread to my brain, spinal cord, or its coverings.

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I have issues with my digestive system that might affect my ability to take pills.

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My cancer originated in the brain or spinal cord.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse events

Dose Limiting Toxicities

Secondary study objectives

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

Disease Control Rate (DCR)

Duration of Response (DOR)

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: RMC-9805 plus RMC-6236 combination armExperimental Treatment2 Interventions

Dose exploration and dose expansion

Group II: RMC-9805 monotherapy armExperimental Treatment1 Intervention

Dose exploration and dose expansion

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, chemotherapy, and immunotherapy. Targeted therapies, such as EGFR inhibitors (osimertinib, erlotinib) and ALK inhibitors, work by specifically targeting genetic mutations that drive cancer growth, offering a more personalized treatment approach. For patients with KRAS mutations, like those in the RMC-9805 trial, targeted inhibitors aim to block the KRAS protein's function, potentially halting tumor growth. Chemotherapy, using agents like cisplatin and paclitaxel, kills rapidly dividing cells but can affect both cancerous and healthy cells. Immunotherapy, including PD-1/PD-L1 inhibitors, boosts the body's immune response to recognize and destroy cancer cells. Understanding these mechanisms helps tailor treatments to individual patients' genetic profiles, improving efficacy and minimizing side effects.

The efficacy of combining antiangiogenic agents with chemotherapy for patients with advanced non-small cell lung cancer who failed first-line chemotherapy: a systematic review and meta-analysis.