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โ† Trials
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A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllRelay Therapeutics, Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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) \>2ร—ULN. * Central nervous system (CNS) metastases that are associated with progressive neurologic symptoms or require ongoing corticosteroids to control the CNS disease.
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What it tests

  • RLY-8161
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Where

9 sites
University of California, Los Angeles
Los Angeles, United States
University of California, San Francisco
San Francisco, United States
University of Colorado Hospital
Aurora, United States
Massachusetts General Hospital
Boston, United States
Dana Farber Cancer Institute
Boston, United States
START Midwest, LLC
Grand Rapids, United States
Memorial Sloan Kettering Cancer Center
New York, United States
Sarah Cannon Research Institute Oncology Partners
Nashville, United States

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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