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Trial NCT07584226

A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors

Phase
Phase 1
Sponsor
Relay Therapeutics, Inc.
Conditions
Advanced NRAS-Mutant Melanoma; Advanced NRAS-Mutant Solid Tumors; NRAS Mutation; NRAS G12D; NRAS G13R; NRAS G13D; NRAS G12V; NRAS Q61R; NRAS Q61K; NRAS Q61L; NRAS Q61H
Ages
18+ years
View on ClinicalTrials.gov ↗

Eligibility criteria

Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).

Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.Performance status * 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.Brain metastases

Restrictions found (2)

Recruiting in Massachusetts

  • Massachusetts General Hospital · Boston, Suffolk County
  • Dana Farber Cancer Institute · Boston, Suffolk County