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

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NCT07584226 · readout in 497 d

Sponsored by Relay Therapeutics, Inc. (industry) · RLAY — their whole pipeline →.

Phase

Phase 1

Status

Recruiting

Study type

Interventional

Design

Non randomized · None · Treatment

Enrollment

35estimated

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2026-03-09

actual

When the study began enrolling

Primary completion

2027-12-30

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2029-12-31

estimated

The whole study's end, after follow-up

First posted

2026-05-13

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-07-02

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

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

Intervention

Drug: RLY-8161

Primary outcomes

what the primary-completion date above is the date OF

Part 1: Maximum Tolerated Dose (MTD) and/or RP2D of RLY-8161

measured 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

Part 1: Number of participants with Adverse Events (AEs) or Serious Adverse Events (SAEs), with changes in vital signs, electrocardiograms (ECGs), and laboratory tests

measured Cycle 1 (28-day cycle) of treatment and at the end of every cycle (28-day cycle) until 30 days after treatment discontinuation, approximately 13 months

Part 2: Objective Response Rate (ORR) of RLY-8161 as assessed by RECIST v1.1

measured Approximately every 8 weeks on treatment and every 12 weeks after last dose in the absence of progressive disease, approximately 18 months

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