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A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations

NCT05907304 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-02-27

No results posted yet for this study

Summary

To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors

* To evaluate the safety and tolerability of naporafenib administered with trametinib in patients with RAS Q61X solid tumors
* To characterize the pharmacokinetic (PK) profile of naporafenib and trametinib when administered to patients with RAS Q61X solid tumors

Conditions

  • Advanced or Metastatic Solid Tumors

Interventions

DRUG

Naporafenib

Naporafenib (ERAS-254) 200 mg twice daily (BID) of an experimental Pan-Raf inhibitor

DRUG

Trametinib

Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.

Sponsors & Collaborators

  • Erasca, Inc.

    lead INDUSTRY

Principal Investigators

  • Joyce Antal, MS · Clinical Development

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-17
Primary Completion
2025-07-01
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • South Korea
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05907304 on ClinicalTrials.gov