Back to search results

RLY-8161 for Advanced NRAS-Mutant Solid Tumors

This study is testing a new drug called RLY-8161 for people with advanced solid tumors, including melanoma, that have a specific genetic change called an NRAS mutation. RLY-8161 is designed to target and block the NRAS mutation. The study aims to find the safest and most effective dose of RLY-8161, understand its side effects, and see if it can shrink tumors. You might be able to join if you have unresectable (cannot be removed by surgery) Stage III or IV melanoma or another solid tumor with an NRAS mutation, and your disease has not responded to standard treatments, or you cannot tolerate them, or have chosen not to have them. The study will measure how many participants experience tumor shrinkage.

Study design
This is a Phase 1, open-label (meaning you and your doctors will know what treatment you are receiving) study involving multiple centers. It plans to enroll 35 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for safety for about 30 days after stopping treatment, and for tumor response for approximately 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07584226

A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Relay Therapeutics, Inc.
~35 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:RLY-8161

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161
Measured over Cycle 1 (28-day cycle) of treatment for MTD and at the end of every cycle (28-day cycle) for RP2D until treatment discontinuation, approximately 12 months
+2 more outcomes measured

Conditions

Advanced NRAS-Mutant Melanoma
Advanced NRAS-Mutant Solid Tumors
NRAS Mutation
NRAS G12D
NRAS G13R
NRAS G13D
NRAS G12V
NRAS Q61R
NRAS Q61K
NRAS Q61L
NRAS Q61H

Explore related trials

MelanomaSolid NeoplasmNRAS Gene

Where it's being run

9 sites across 7 states
California2
Massachusetts2
Colorado1
Michigan1
New York1
Tennessee1
Virginia1

Who to contact

Relay Therapeutics, Inc
[email protected]
617-322-0731
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Histologically confirmed diagnosis of unresectable Stage III or IV melanoma or other solid tumor.
Disease is refractory to standard therapy (including targeted therapy), participant is intolerant of standard therapy, or participant has declined standard therapy.
Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
One or more documented primary oncogenic NRAS mutation(s).

Exclusion

Known activating KRAS, HRAS, or BRAF mutation or known alterations in other driver oncogenes.
Prior treatment with ERK, MEK, RAF, or RAS targeting agents or any agent whose mechanism of action is to inhibit the RAS-MAPK pathway.
For participants with melanoma: lactate dehydrogenase (LDH) \>2×ULN.
Central nervous system (CNS) metastases that are associated with progressive neurologic symptoms or require ongoing corticosteroids to control the CNS disease.

What this trial measures

  • Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161Cycle 1 (28-day cycle) of treatment for MTD and at the end of every cycle (28-day cycle) for RP2D until treatment discontinuation, approximately 12 months
  • Part 1: Number of participants with Adverse Events (AEs) or Serious Adverse Events (SAEs), with changes in vital signs, electrocardiograms (ECGs), and laboratory testsCycle 1 (28-day cycle) of treatment and at the end of every cycle (28-day cycle) until 30 days after treatment discontinuation, approximately 13 months
  • Part 2: Objective Response Rate (ORR) of RLY-8161 as assessed by RECIST v1.1Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months