RecruitingRecruiting
A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
NCT07584226 · Relay Therapeutics, Inc.
In plain English
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Official title
A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors
About this study
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.
Eligibility criteria
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 target: 35 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-09
Estimated completion: 2029-12-31
Last updated: 2026-06-02
Interventions
Drug: RLY-8161
Primary outcomes
- • 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)
Sponsor
Relay Therapeutics, Inc. · industry
Contacts & investigators
ContactRelay Therapeutics, Inc · contact · ClinicalTrials@relaytx.com · 617-322-0731
All locations (6)
University of California, Los Angeles (UCLA) Department of MedicineRecruiting
Los Angeles, California, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
START Midwest, LLCRecruiting
Grand Rapids, Michigan, United States
Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Sarah Cannon Research Institute (SCRI) Oncology PartnersRecruiting
Nashville, Tennessee, United States
NEXT VirginiaRecruiting
Fairfax, Virginia, United States