Recruiting
Phase 1

RLY-8161

Sponsor:

Relay Therapeutics, Inc.

Code:

NCT07584226

Conditions

Advanced NRAS-Mutant Melanoma

Advanced NRAS-Mutant Solid Tumors

NRAS Mutation

NRAS G12D

NRAS G13R

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RLY-8161

Study Details

Brief 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

Advanced NRAS-Mutant Melanoma

Advanced NRAS-Mutant Solid Tumors

NRAS Mutation

NRAS G12D

NRAS G13R

Study ID

NCT07584226

Start date

Mar 9, 2026

Status verified date

Jun, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

  • 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.

Study Design

Enrollment

35 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Multiple doses of RLY-8161 for oral administration

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

Interventions

RLY-8161

RLY-8161 is an NRAS-selective inhibitor

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Relay Therapeutics, Inc

617-322-0731ClinicalTrials@relaytx.com

Locations

University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Bartosz Chmielowski, MD

310-794-4655bchmielowski@mednet.ucla.edu

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Sonia C Martinez

415-714-4484Sonia.ContrerasMartinez@ucsf.edu

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Meagan Brander

303-724-8869MAEGAN.BRANDER@CUANSCHUTZ.EDU

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Ryan Sullivan, MD

617-243-5480RSULLIVAN7@mgh.harvard.edu

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Linnea Drew

617-632-6704Linneam_drew@dfci.harvard.edu

START Midwest, LLC

Recruiting

Grand Rapids, Michigan, United States, 49546

Contacts

616-954-5554hopeteam@startresearch.com

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Monica Chen, MD

646-888-5108ChenM9@mskcc.org

Sarah Cannon Research Institute Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

ASKSarah

877-MY-1-SCRI (691-7274)ASKSARAH@scresearch.net

NEXT Virginia

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Paolo Umayam

703-783-4546pumayam@nextoncology.com

More Information

Sponsor

Relay Therapeutics, Inc.

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Relay Therapeutics, Inc. on 2026-07-02.