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RecruitingNCT07584226Updated Jul 2, 2026

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

A Phase 1 interventional study of RLY-8161 in Advanced NRAS-Mutant Melanoma, Advanced NRAS-Mutant Solid Tumors and NRAS Mutation, sponsored by Relay Therapeutics, Inc.. Recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-02.

Sponsored by Relay Therapeutics, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

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. This study consists of 2 parts: dose escalation (Part 1) and dose expansion (Part 2).

Part 1, dose escalation will explore multiple ascending doses of RLY-8161 in participants with any advanced NRAS-mutant solid tumor until maximum tolerated dose is reached or one or more recommended Phase 2 dose (RP2D) is identified.

Part 2, dose expansion will be at the RP2D(s) identified in Part 1 in NRAS-mutant solid tumors.

02

Conditions studied

  • 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
03

In context

Lead sponsor

Relay Therapeutics, Inc. is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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 criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
35 participants (estimated)

Study arms

  • Experimental
    Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumors

    Multiple doses of RLY-8161 for oral administration

    Drug: RLY-8161

  • Experimental
    Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumors

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

    Drug: RLY-8161

Interventions

  • DrugRLY-8161

    RLY-8161 is an NRAS-selective inhibitor

06

What researchers measure

Primary outcomes

  1. Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161

    Time frame: 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. Part 1: Number of participants with Adverse Events (AEs) or Serious Adverse Events (SAEs), with changes in vital signs, electrocardiograms (ECGs), and laboratory tests

    Time frame: Cycle 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

  3. Part 2: Objective Response Rate (ORR) of RLY-8161 as assessed by RECIST v1.1

    Time frame: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months

Secondary outcomes

  1. Part 1 and Part 2: Changes in NRAS mutant allele fraction in ctDNA

    Time frame: Approximately every 2 weeks in Cycle 1 (28-day cycle), at the beginning of Cycle 2 (28-day cycle), and at the beginning of every odd cycle (28-day cycle) until End of Treatment (EOT), approximately 12 months

  2. Part 1 and Part 2: Plasma concentration and PK parameters of RLY-8161

    Time frame: Approximately every 2 weeks in Cycle 1 (28-day cycle) and at Day 1 of every cycle (28-day cycle) through Cycle 4

  3. Part 1: ORR of RLY-8161 as assessed by RECIST v1.1

    Time frame: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months

  4. Part 1 and 2: Duration of Response (DOR) of RLY-8161 as assessed by RECIST v1.1

    Time frame: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months

  5. Part 1 and 2: Disease Control Rate (DCR) of RLY-8161 as assessed by RECIST v1.1

    Time frame: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months

  6. Part 2: Progression-free survival (PFS) as assessed by RECIST v1.1

    Time frame: Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months

  7. Part 2: Overall Survival

    Time frame: Cycle 1 (28-day cycles) until study completion, approximately 30 months

  8. Part 2: Number of participants with AEs or SAEs, with changes in vital signs, ECGs, and laboratory tests

    Time frame: Cycle 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

07

Study locations

9 of 9 sites recruiting
  • University of California, Los Angeles
    Los Angeles, California 90095, United States
    Recruiting
  • University of California, San Francisco
    San Francisco, California 94143, United States
    Recruiting
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
    Recruiting
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
    Recruiting
  • START Midwest, LLC
    Grand Rapids, Michigan 49546, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
    Recruiting
  • Sarah Cannon Research Institute Oncology Partners
    Nashville, Tennessee 37203, United States
    Recruiting
  • NEXT Virginia
    Fairfax, Virginia 22031, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07584226
Lead sponsor
Relay Therapeutics, Inc.
Responsible party
Sponsor
First posted
May 13, 2026
Start date
Mar 9, 2026
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jul 2, 2026

Study contacts

Relay Therapeutics, Inc
Contact
ClinicalTrials@relaytx.com
617-322-0731

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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