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
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)
- Brain metastasesConditionalexclusionShow in the text
- Performance statusConditionalinclusion
ECOG 0 to 1
Show in the text
Recruiting in Massachusetts
- Massachusetts General Hospital · Boston, Suffolk County
- Dana Farber Cancer Institute · Boston, Suffolk County