A First-in-human Study of RLY-8161 for Treatment of Advanced NRAS-Mutant Melanoma and Other Solid Tumors

Study Identifier:
RLY-8161-101
CT.gov Identifier:
NCT07584226
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

Considering participating in a START clinical trial?

Get Started

Study Summary

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I
Sex
N/A
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumors
Read More
Drug: Multiple doses of RLY-8161 for oral administration
Drug: Drug: RLY-8161
Drug: RLY-8161 is an NRAS-selective inhibitor
Drug: EXPERIMENTAL: Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumors
Drug: Oral doses of RLY-8161 as determined during Part 1 Dose Escalation
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
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.

Clinical Study Information for Healthcare Providers

By clicking the button below you will find in-depth information about this clinical trial, including study design, primary and secondary endpoints, and more. This information is intended for healthcare professionals seeking to review the scientific and operational aspects of the study.

View Study Information

Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Midwest
Grand Rapids, MI, United States, 49546
Investigator
Sreenivasa Chandana
Status
Will Be Recruiting
Condition(s) Treated at Site