RLY-8161 for Melanoma

Recruiting at 3 trial locations

Overseen By Relay Therapeutics, Inc

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Relay Therapeutics, Inc.

Must not be taking: ERK inhibitors, MEK inhibitors

Disqualifiers: KRAS, HRAS, BRAF mutations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, RLY-8161, to determine its safety and effectiveness for individuals with advanced melanoma or other solid tumors with a specific gene mutation called NRAS. The study will explore different doses to identify the most effective one. Individuals with melanoma or other solid tumors that no longer respond to standard treatments and who have the NRAS mutation may be suitable candidates for this trial. Participants should not have certain other gene mutations or cancer-related brain issues. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that RLY-8161 is likely to be safe for humans?

Research has shown that RLY-8161 is being tested to assess its safety and tolerability. This drug represents a new treatment aimed at combating certain cancers with specific genetic changes, such as NRAS-mutant melanoma. As this is the first human trial, information about its safety remains limited.

In these early stages, researchers focus primarily on determining RLY-8161's safety and potential side effects. Early trials like this are conducted with meticulous care and close monitoring to ensure participant safety.

Currently, no specific reports on side effects or adverse events for RLY-8161 exist from previous studies. However, as a Phase 1 trial, safety data is still being collected and evaluated. Participants in this trial will contribute to a better understanding of the drug's safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for melanoma?

RLY-8161 is unique because it targets NRAS-mutant melanoma, a specific type of genetic mutation that current treatments like immunotherapy and targeted therapy often struggle to address. Most existing treatments for melanoma work by boosting the immune system or targeting the BRAF mutation, but RLY-8161 works differently by directly targeting the NRAS mutation, which could lead to more effective outcomes for patients with this specific mutation. Researchers are excited about RLY-8161 because it offers a new mechanism of action and is administered orally, potentially providing a more convenient and targeted option for patients.

What evidence suggests that RLY-8161 might be an effective treatment for melanoma?

Research has shown that RLY-8161 targets specific changes, known as NRAS mutations, found in some aggressive types of skin cancer, such as melanoma. These mutations can make melanoma more difficult to treat, so the drug aims to block them. Early lab studies suggest that targeting NRAS might slow tumor growth. In this trial, participants will receive RLY-8161 in two parts: Part 1 involves multiple doses for those with advanced NRAS-mutant solid tumors, and Part 2 will administer oral doses as determined during Part 1. The treatment remains in the early stages of testing in people, so more information is needed to assess its effectiveness. By focusing on NRAS, RLY-8161 might offer a new way to manage tumors with this mutation. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, like melanoma or lung cancer, that have an NRAS mutation. Participants must be in good physical condition (able to care for themselves), have disease that can't be removed by surgery and has not responded to standard treatments, or cannot tolerate them.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity only.

I have been diagnosed with Stage III or IV melanoma or another solid tumor that can't be removed.

My disease did not respond to, I cannot tolerate, or I declined standard treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Multiple ascending doses of RLY-8161 are administered to determine the maximum tolerated dose or recommended Phase 2 dose

Variable duration until dose determination

Dose Expansion

Participants receive RLY-8161 at the recommended Phase 2 dose identified in Part 1

Variable duration based on response

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RLY-8161

Trial Overview

The study is testing RLY-8161, a new drug designed to target cancers with NRAS mutations. It's the first time this drug is being given to people. The main goals are to check its safety and how well patients tolerate it.

How Is the Trial Designed?

Group I: Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumors Experimental Treatment 1 Intervention

Oral doses of RLY-8161 as determined during Part 1 Dose Escalation

Group II: Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumors Experimental Treatment 1 Intervention

Multiple doses of RLY-8161 for oral administration

Who Is Running the Clinical Trial?

Relay Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

1,900+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07584226

A First-in-human Study of RLY-8161 in Advanced NRAS- ...

This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and ...

2.

ir.relaytx.com

ir.relaytx.com/news-releases/news-release-details/relay-therapeutics-reports-first-quarter-2026-financial-results

Relay Therapeutics Reports First Quarter 2026 Financial ...

Additionally, RLY-8161, our NRAS-selective molecule, has entered clinical development for patients with NRAS-mutant solid tumors. We remain ...

3.

withpower.com

withpower.com/trial/phase-1-nras-mutation-2-2026-90fda

RLY-8161 for Melanoma · Recruiting Participants for Phase ...

This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), ...

4.

mskcc.org

mskcc.org/cancer-care/clinical-trials/26-072

A Study of RLY-8161 in People With Solid Tumor Cancer

A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors. Purpose. To learn more about the purpose of this ...

5.

sec.gov

sec.gov/Archives/edgar/data/1812364/000119312526206398/rlay-ex99_1.htm

EX-99.1

Additionally, RLY-8161, our NRAS-selective molecule, has entered clinical development for patients with NRAS-mutant solid tumors. We remain ...

6.

trialstoday.org

trialstoday.org/trial/NCT07584226

A First-in-human Study of RLY-8161 in Advanced NRAS- ...

This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), ...