A First-in-human Study of RLY-8161 in Advanced NRAS-Mutant Solid Tumors

a study on NRAS Gene Mutation Skin Cancer/Melanoma Solid Tumor NRAS G12D NRAS G13R NRAS G13D NRAS G12V NRAS Q61R NRAS Q61K NRAS Q61L NRAS Q61H

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
study ends around

Description

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.

Official Title

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

Details

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. This study consists of 2 parts: dose escalation (Part 1) and dose expansion (Part 2).

Part 1, dose escalation will explore multiple ascending doses of RLY-8161 in participants with any advanced NRAS-mutant solid tumor until maximum tolerated dose is reached or one or more recommended Phase 2 dose (RP2D) is identified.

Part 2, dose expansion will be at the RP2D(s) identified in Part 1 in NRAS-mutant solid tumors.

Keywords

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, RLY-8161

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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).

You 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 CNS disease.

Locations

  • University of California, Los Angeles (UCLA) Department of Medicine accepting new patients
    Los Angeles California 90095 United States
  • Sarah Cannon Research Institute (SCRI) Oncology Partners accepting new patients
    Nashville Tennessee 37203 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Relay Therapeutics, Inc.
ID
NCT07584226
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 35 study participants
Last Updated
Contact us about this trial