A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations
Solid Tumor
Unknown Primary
12 - 99 Years, Male and Female
ERAS-254-01 (primary)
NCI-2024-00013
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
Objectives
SEACRAFT-1 is an open-label study to assess the safety and efficacy of naporafenib
administered with trametinib in previously treated patients with locally advanced
unresectable or metastatic RAS Q61X solid tumor malignancies. The study will enroll a
total of approximately 100 adult patients; a sub-study will enroll approximately 15
adolescent patients =12 and <18 years for a total sample size of approximately 115.
Patients with a locally advanced unresectable or metastatic solid tumor malignancy that
is not responsive to standard therapies or for which there is no standard therapy are
eligible. Patients with primary central nervous system (CNS) tumors are not eligible.
Documentation of a RAS Q61X mutation in tumor tissue prior to the first dose of study
treatment is required.
Eligibility
- 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.
Treatment Sites in Georgia
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