A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
Recruiting
Phase 1
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 35 (estimated)
- Sponsor
- Relay Therapeutics, Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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…
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