A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X M… (NCT05907304) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations
United States86 participantsStarted 2023-08-17
Plain-language 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
Who can participate
Age range12 Years – 99 Years
SexALL
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Inclusion criteria
✓. Willing and able to provide written informed consent
✓. Age ≥ 12 years
✓. 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.
✓. 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.
✓. 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.
✓. ECOG performance status 0, 1 or 2
✓. Presence of at least 1 measurable lesion according to RECIST v1.1
✓. Able to swallow oral medication.
Exclusion criteria
✕. 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)
What they're measuring
1
To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors
Timeframe: Assessed up to 24 months from time of first dose
✕. 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;