First-in-human use of RLY-8161 in advanced NRAS-mutant solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, first-in-human, open-label multicenter trial tests RLY-8161, an NRAS-selective inhibitor, in participants with advanced NRAS-mutant melanoma and other NRAS-mutant solid tumors. Part 1 uses dose-escalation to identify a maximum tolerated dose or recommended Phase 2 dose with close monitoring of safety, tolerability, pharmacokinetics, and pharmacodynamics. Part 2 expands cohorts at the selected dose(s) to gather preliminary antitumor activity assessed by RECIST v1.1 and to explore biomarker effects. Enrollment requires documented oncogenic NRAS mutation, ECOG 0–1, measurable disease, and prior standard therapy failure, while patients with other driver mutations or prior RAS-MAPK pathway inhibitors are excluded.

Why it matters

Who can join: the full rules

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, 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.

Where it's running

• University of California, Los Angeles
  Los Angeles, California, United States Recruiting
• University of California, San Francisco
  San Francisco, California, United States Recruiting
• University of Colorado Hospital
  Aurora, Colorado, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• START Midwest, LLC
  Grand Rapids, Michigan, United States Recruiting

Study contacts

• Study coordinator: Relay Therapeutics, Inc
• Email: ClinicalTrials@relaytx.com
• Phone: 617-322-0731

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.