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

Conditions

• Advanced NRAS-Mutant Melanoma
• Advanced NRAS-Mutant Solid Tumors
• NRAS G12D
• NRAS G12V
• NRAS G13D
• NRAS G13R
• NRAS Mutation
• NRAS Q61H
• NRAS Q61K
• NRAS Q61L
• NRAS Q61R

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• RLY-8161 — DRUG
  RLY-8161 is an NRAS-selective inhibitor

Study 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.

Key Dates

First listed

May 13, 2026

Start date

Mar 9, 2026

Status verified

Jun 2026

Primary completion

Dec 30, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

35 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: RLY-8161 for participants with advanced NRAS-mutant solid tumors
  Multiple doses of RLY-8161 for oral administration
• Experimental: Part 2: RLY-8161 for participants with advanced NRAS-mutant solid tumors
  Oral doses of RLY-8161 as determined during Part 1 Dose Escalation

Primary Outcome Measure

Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161 [ Time Frame: Cycle 1 (28-day cycle) of treatment for MTD and at the end of every cycle (28-day cycle) for RP2D until treatment discontinuation, approximately 12 months ]

Central Contacts

• Relay Therapeutics, Inc
  617-322-0731
  [email protected]

Locations (9)

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