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RLY-8161

Phase 1

Advanced NRAS-Mutant Melanoma | Small molecule | Oncology |Relay Therapeutics, Inc.|Last Updated: Jul 2, 2026

Target and mechanism

Molecular targetNRAS
Target classGene
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

RLY-8161 · 1 trial · 11 indications

Phase 1 1
NCT07584226A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid TumorsAdvanced NRAS-Mutant Melanoma
RECRUITING35 Analytics
PHASE1RECRUITING
A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
Advanced NRAS-Mutant Melanoma
NCT0758422635
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Study Endpoints

Primary Endpoints

Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161
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
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
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months

Secondary Endpoints

Part 1 and Part 2: Changes in NRAS mutant allele fraction in ctDNA
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
Part 1 and Part 2: Plasma concentration and PK parameters of RLY-8161
Approximately every 2 weeks in Cycle 1 (28-day cycle) and at Day 1 of every cycle (28-day cycle) through Cycle 4
Part 1: ORR of RLY-8161 as assessed by RECIST v1.1
Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumorsEXPERIMENTALMultiple doses of RLY-8161 for oral administration
Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumorsEXPERIMENTALOral doses of RLY-8161 as determined during Part 1 Dose Escalation

Interventions

NameTypeDescription
RLY-8161DRUGRLY-8161 is an NRAS-selective inhibitor
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

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 st...

Countries:United States
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Recent Changes (Last 90 Days)

LOWJul 2, 2026NCT07584226lastUpdatePostDate: changed
LOWJul 2, 2026NCT07584226lastUpdatePostDate: changed
LOWJul 2, 2026NCT07584226lastUpdatePostDate: changed

Frequently asked questions about RLY-8161

What is RLY-8161 used for?

RLY-8161 is an investigational small molecule being developed for the treatment of advanced NRAS-mutant melanoma. It is also being studied in other advanced NRAS-mutant solid tumors. The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does RLY-8161 target?

RLY-8161 targets NRAS, a gene that is mutated in certain cancers. By targeting NRAS, the drug aims to interfere with the signaling pathways that drive tumor growth in cancers harboring NRAS mutations, including specific mutations such as G12D, G13R, G13D, G12V, Q61R, Q61K, Q61L, and Q61H.

Who is developing RLY-8161?

RLY-8161 is being developed by Relay Therapeutics, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol RLAY. Relay Therapeutics is conducting clinical trials to evaluate the safety and efficacy of RLY-8161 in patients with advanced NRAS-mutant solid tumors.

What phase is RLY-8161 in?

RLY-8161 is in Phase 1 clinical development. It is currently being evaluated in a first-in-human study that is recruiting participants. The drug is investigational and has not yet received regulatory approval for any indication.

What clinical trials is RLY-8161 in?

RLY-8161 is being studied in a Phase 1 clinical trial with the identifier NCT07584226. This is a first-in-human study of RLY-8161 in advanced NRAS-mutant solid tumors, including advanced NRAS-mutant melanoma. The trial is recruiting participants in the United States and has an enrollment target of 35 patients.

Is RLY-8161 the same as other NRAS-targeting drugs?

RLY-8161 is a distinct investigational drug developed by Relay Therapeutics. It is specifically designed to target NRAS mutations. While other drugs may also target NRAS, RLY-8161 is a unique compound being studied for its potential in treating advanced NRAS-mutant solid tumors.