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

Running, not enrolling · Phase 1

Conditions studied: Advanced or Metastatic Solid Tumors

In brief

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 facts

Study ID

NCT05907304

Run by

Erasca, Inc.

People needed

86

Starts

2023-08-17

Expected to finish

2026-12-01

Last updated by the study team

2026-02-27

Who can join

Age: 12 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor
• 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)
• 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)
• 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
• LVEF <50%
• All primary CNS tumors
• Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible.
• 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;
• Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

Where it is running

• University of California, San Francisco — San Francisco, California, United States
• Yale Cancer Center — New Haven, Connecticut, United States
• Florida Cancer Specialists - Sarasota — Sarasota, Florida, United States
• Florida Cancer Specialists - St. Petersburg — St. Petersburg, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Comprehensive Cancer Center of Nevada (CCCN) — Las Vegas, Nevada, United States
• Oregon Health & Science University — Portland, Oregon, United States
• SCRI Oncology Partners (formerly Tennessee Oncology) — Nashville, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• Inova Schar Cancer Institute — Fairfax, Virginia, United States
• NEXT Virginia — Fairfax, Virginia, United States
• University of Wisconsin — Madison, Wisconsin, United States
• Macquarie University — Macquarie Park, New South Wales, Australia
• St. Vincent's Hospital — Melbourne, Victoria, Australia
• Linear Clinical Research, LTD — Perth, Australia
• Cross Cancer Institute- Alberta Health Services (AHS) — Edmonton, Alberta, Canada
• British Columbia Cancer Agency — Vancouver, British Columbia, Canada
• London Regional Cancer Center — London, Ontario, Canada
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Inje University Haeundae Paik Hospital — Busan, Busan Gwang'yeogsi, South Korea
• Samsung Medical Center — Seoul, Seoul Teugbyeolsi, South Korea
• National Cancer Center — Goyang-si, South Korea
• Seoul National University Hospital Bundang — Gyeonggi-do, South Korea

Full record on ClinicalTrials.gov

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