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

NCT07584226 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2026-05-13

No results posted yet for this study

Summary

This is a Phase 1 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other solid tumors.

Conditions

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

Interventions

DRUG

RLY-8161

RLY-8161 is an NRAS-selective inhibitor

Sponsors & Collaborators

  • Relay Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2027-12-30
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584226 on ClinicalTrials.gov