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

Part of paid clinical trials in San Francisco, California.

Sponsor
Erasca, Inc.
Study ID
NCT05907304
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced or Metastatic Solid Tumors

Eligibility Criteria

Sex
ALL
Age
12 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Naporafenib — DRUG
    Naporafenib (ERAS-254) 200 mg twice daily (BID) of an experimental Pan-Raf inhibitor
  • Trametinib — DRUG
    Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.

Study Details

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

Key Dates

Start date
Aug 17, 2023
Status verified
Feb 2026
Primary completion
Jul 1, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
86 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Naporafenib + Trametinib
    Naporafenib (ERAS-254) 200 mg twice daily (BID) Trametinib 1 mg once daily (QD)

Primary Outcome Measure

To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors [ Time Frame: Assessed up to 24 months from time of first dose ]

Locations (14)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143-
Yale Cancer CenterNew HavenConnecticut06510-
Florida Cancer Specialists - SarasotaSarasotaFlorida34232-
Florida Cancer Specialists - St. PetersburgSt. PetersburgFlorida33705-
Emory University School of MedicineAtlantaGeorgia30322-
Henry Ford Health SystemDetroitMichigan48202-
Washington University School of MedicineSt LouisMissouri63110-
Comprehensive Cancer Center of Nevada (CCCN)Las VegasNevada89169-
Oregon Health & Science UniversityPortlandOregon97239-
SCRI Oncology Partners (formerly Tennessee Oncology)NashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Inova Schar Cancer InstituteFairfaxVirginia22031-
NEXT VirginiaFairfaxVirginia22031-
University of WisconsinMadisonWisconsin53792-

Find similar trials in San Francisco, CA

By research site
University of California, San Francisco· San Francisco, CAYale Cancer Center· New Haven, CTFlorida Cancer Specialists - Sarasota· Sarasota, FLFlorida Cancer Specialists - St. Petersburg· St. Petersburg, FLEmory University School of Medicine· Atlanta, GAHenry Ford Health System· Detroit, MI

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