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New treatment option for Advanced NRAS-Mutant Melanoma
Official title A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors
ClinicalTrials.gov ID: NCT07584226
What this study is testing
What is RLY-8161?
RLY-8161 is an investigational medicine, being studied as a potential treatment for advanced nras-mutant melanoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- One or more documented primary oncogenic NRAS mutation(s).
You likely can't join if
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Boston, Massachusetts, United States
- Grand Rapids, Michigan, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Boston, Massachusetts, United States; Grand Rapids, Michigan, United States; New York, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.