Active Not RecruitingPhase 1NCT05907304

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

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

Checked against the public recordLast updated Feb 27, 2026 · Source: ClinicalTrials.gov

StatusActive Not Recruiting
PhasePhase 1
U.S. locations29
SponsorErasca, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Erasca, Inc.
Interventions being studied
Drug: Naporafenib; Drug: Trametinib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

Key Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Age ≥ 12 years 3. A locally advanced or metastatic tumor who has progressed on or for which no standard therapy exists. Patients who are intolerant to standard therapy or who are not a candidate for standard therapy (in the opinion of the Investigator) or who decline standard therapy are also eligible. 4. Documentation of a RAS Q61X mutation (tumor tissue or blood) prior to first dose of study treatment as determined locally with an analytically validated assay in a certified testing laboratory. 5. Archival tumor tissue collected within 5 years prior to enrollment must be confirmed to be available at the time of Screening, which may be submitted before or after enrollment for exploratory biomarker analysis. 6. ECOG performance status 0, 1 or 2 7. Presence of at least 1 measurable lesion according to RECIST v1.1 8. Able to swallow oral medication. Exclusion Criteria: 1. Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor 2. Impairment of GI function or gastrointestinal (GI) disease that may significantly alter the absorption of study treatment (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection) 3. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndrome) 4. Corrected QT interval using Fridericia's formula (QTcF) at Screening \>450 ms based on triplicate average NOTE: criterion does not apply to patients with a right or left bundle branch block 5. LVEF \<50% 6. All primary CNS tumors 7. Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible. 8. Patients receiving treatment with medications that are known to be strong inhibitors and/or inducers of cytochrome P450 (CYP)3A; substrates of CYP2C8, CYP2C9, and CYP3A with a narrow therapeutic index and sensitive substrates of CYP3A; 9. Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • University of California, San FranciscoSan Francisco, California
  • Yale Cancer CenterNew Haven, Connecticut
  • Florida Cancer Specialists - SarasotaSarasota, Florida
  • Florida Cancer Specialists - St. PetersburgSt. Petersburg, Florida
  • Emory University School of MedicineAtlanta, Georgia
  • Henry Ford Health SystemDetroit, Michigan
  • Washington University School of MedicineSt Louis, Missouri
  • Comprehensive Cancer Center of Nevada (CCCN)Las Vegas, Nevada
  • Oregon Health & Science UniversityPortland, Oregon
  • SCRI Oncology Partners (formerly Tennessee Oncology)Nashville, Tennessee
  • The University of Texas MD Anderson Cancer CenterHouston, Texas
  • Inova Schar Cancer InstituteFairfax, Virginia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 27, 2026. Always confirm current availability with the study team.

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