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Clinical Trials in the UK / NCT05907304
Active, not recruiting Phase 1

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

NCT05907304 · tracked via the Priya Life Science UK tracker
Sponsor
Erasca, Inc.
Phase
Phase 1
Started
2023-08-17
Last updated
2026-02-27

Condition(s) studied

Advanced or Metastatic Solid Tumors

Investigational drug(s) / intervention(s)

NaporafenibTrametinib

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

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

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

Eligibility

Sex
ALL
Min age
12 Years
Max age
99 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (29)

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

More Erasca, Inc. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05907304 on ClinicalTrials.gov ↗ ← All trials in the UK