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Advanced NRAS-Mutant MelanomaPhase 1/2NCT07584226

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

A Phase 1/2 study testing RLY-8161 in people with Advanced NRAS-Mutant Melanoma and Advanced NRAS-Mutant Solid Tumors, run by Relay Therapeutics, Inc. at 9 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase 1/2 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, colorectal and other solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RLY-8161
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
9 sitesUnited States
Study dates
9 Mar 2026to 30 Jun 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • Known activating KRAS, HRAS, BRAF, or EGFR mutation or known alterations in other driver oncogenes that are recognized as actionable oncogenic drivers for the participant's specific tumor type.
  • 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 associated with progressive neurologic symptoms or requiring ongoing corticosteroids to control the CNS disease.

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Relay Therapeutics, Inc contact

617-322-0731

ClinicalTrials@relaytx.com

9 sites in 1 country

United States9 sites, 9 recruiting

  • University of Colorado Hospital

    Aurora, Colorado, 80045

    Meagan Brander, 303-724-8869, MAEGAN.BRANDER@CUANSCHUTZ.EDU

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Ryan Sullivan, MD, 617-243-5480, RSULLIVAN7@mgh.harvard.edu

    Recruiting

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

    Linnea Drew, 617-632-6704, Linneam_drew@dfci.harvard.edu

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Paolo Umayam, 703-783-4546, pumayam@nextoncology.com

    Recruiting

  • START Midwest, LLC

    Grand Rapids, Michigan, 49546

    616-954-5554, hopeteam@startresearch.com

    Recruiting

  • University of California, Los Angeles

    Los Angeles, California, 90095

    Bartosz Chmielowski, MD, 310-794-4655, bchmielowski@mednet.ucla.edu

    Recruiting

  • Sarah Cannon Research Institute Oncology Partners

    Nashville, Tennessee, 37203

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

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Monica Chen, MD, 646-888-5108, ChenM9@mskcc.org

    Recruiting

  • University of California, San Francisco

    San Francisco, California, 94143

    Sonia C Martinez, 415-714-4484, Sonia.ContrerasMartinez@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors

This is a Phase 1/2 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, colorectal and other solid tumors.

Read the detailed description

This is a Phase 1/2 first-in-human, open-label multicenter study designed to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary antitumor activity of RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma, colorectal 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 (MTD) 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.

Being tested
RLY-8161

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RLY-8161Drug

    RLY-8161 is an NRAS-selective inhibitor

Study groups in NCT07584226
Study groupRoleWhat they receive
Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumorsExperimentalMultiple doses of RLY-8161 for oral administration
Receives: Drug: RLY-8161
Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumorsExperimentalOral doses of RLY-8161 as determined during Part 1 Dose Escalation
Receives: Drug: RLY-8161

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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

    Measured: 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

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

Secondary outcomes (8)

  1. Part 1 and Part 2: Changes in NRAS mutant allele fraction in circulating tumor DNA (ctDNA)

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start9 Mar 2026
  3. Primary completion31 May 2029 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07584226
Sponsor's protocol ID
RLY-8161-101
Status last verified
Oct 2026
First submitted
28 Apr 2026
Last updated
3 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing RLY-8161 in people with Advanced NRAS-Mutant Melanoma and Advanced NRAS-Mutant Solid Tumors, run by Relay Therapeutics, Inc. at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Relay Therapeutics, Inc (617-322-0731, ClinicalTrials@relaytx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07584226.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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