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RLY-8161 · 1 trial · 11 indications
| Arm | Type | Description |
|---|---|---|
| Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumors | EXPERIMENTAL | Multiple doses of RLY-8161 for oral administration |
| Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumors | EXPERIMENTAL | Oral doses of RLY-8161 as determined during Part 1 Dose Escalation |
| Name | Type | Description |
|---|---|---|
| RLY-8161 | DRUG | RLY-8161 is an NRAS-selective inhibitor |
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 st...
RLY-8161 is an investigational small molecule being studied for advanced NRAS-mutant melanoma and other advanced NRAS-mutant solid tumors. It is a biomarker-selected therapy, meaning patients are enrolled based on the presence of specific NRAS mutations such as G12D, G13R, G13D, G12V, Q61R, Q61K, Q61L, or Q61H.
RLY-8161 targets NRAS, a gene that encodes a RAS-family signaling protein. NRAS mutations drive tumor growth in melanoma and other solid tumors. By targeting mutant NRAS, RLY-8161 aims to address a driver alteration that has historically been difficult to drug directly.
RLY-8161 is being developed by Relay Therapeutics, Inc., a biopharmaceutical company that trades on the Nasdaq under the ticker symbol RLAY. Relay Therapeutics is the sponsor of the clinical program evaluating the compound in advanced NRAS-mutant solid tumors.
RLY-8161 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 program is a first-in-human study designed to evaluate the compound in patients with advanced NRAS-mutant solid tumors, including melanoma.
RLY-8161 is being evaluated in one active clinical trial, NCT07584226, titled A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors. The trial is currently recruiting, is expected to enroll approximately 35 participants, and is being conducted in the United States in adults aged 18 years and older.