A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
Recruiting · NCT07584226 · Interventional (participants receive a specific treatment) · Lead sponsor: Relay Therapeutics, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
RLY-8161
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
9 locations listed across 7 US states.
- University of California, Los Angeles - Los Angeles, California, United States
- University of California, San Francisco - San Francisco, California, United States
- University of Colorado Hospital - Aurora, Colorado, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- START Midwest, LLC - Grand Rapids, Michigan, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Sarah Cannon Research Institute Oncology Partners - Nashville, Tennessee, United States
- NEXT Virginia - Fairfax, Virginia, United States