Clinical trial · Interventional
A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors
NCT07584226CI-TRIAL-00116668recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced NRAS-Mutant Melanoma | — | UNRESOLVED | — |
| Advanced NRAS-Mutant Solid Tumors | — | UNRESOLVED | — |
| NRAS G12D | — | UNRESOLVED | — |
| NRAS G12V | — | UNRESOLVED | — |
| NRAS G13D | — | UNRESOLVED | — |
| NRAS G13R | — | UNRESOLVED | — |
| NRAS Mutation | — | UNRESOLVED | — |
| NRAS Q61H | — | UNRESOLVED | — |
| NRAS Q61K | — | UNRESOLVED | — |
| NRAS Q61L | — | UNRESOLVED | — |
| NRAS Q61R | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RLY-8161 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumors
- description
- Multiple doses of RLY-8161 for oral administration
- interventionNames
- Drug: RLY-8161
- type
- EXPERIMENTAL
- label
- Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumors
- description
- Oral doses of RLY-8161 as determined during Part 1 Dose Escalation
- interventionNames
- Drug: RLY-8161
Primary outcomes (3)
- measure
- Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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) \>2×ULN. * Central nervous system (CNS) metastases that are associated with progressive neurologic symptoms or require ongoing corticosteroids to control the CNS disease.
References
Publications (0)
Data not yet available
No reference posted for this study.