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RLY-8161

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment35
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07584226A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid TumorsPHASE1 RECRUITING 35 — — Mar 9, 2026Dec 31, 2029Jun 2, 20266 United States
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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 — N/A
SexALL
Healthy VolunteersNo
Study Sites6

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)
LOWJun 2, 2026NCT07584226lastUpdatePostDate: changed
LOWJun 2, 2026NCT07584226lastUpdatePostDate: changed
LOWJun 2, 2026NCT07584226lastUpdatePostDate: changed
LOWMay 26, 2026NCT07584226primaryCompletionDate: changed
LOWMay 24, 2026NCT07584226studyFirstPostDate: changed
LOWMay 21, 2026NCT07584226NEW_TRIAL: changed
LOWMay 21, 2026NCT07584226NEW_TRIAL: changed