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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
86
Naporafenib (ERAS-254) 200 mg twice daily (BID) of an experimental Pan-Raf inhibitor
Trametinib is an FDA approved anticancer medication that targets MEK1 and MEK2.
To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors
Based on assessment of Objective response rate (ORR) per RECIST version 1.1
Time frame: Assessed up to 24 months from time of first dose
Adverse Events
Incidence and severity of treatment-emergent AEs and serious AEs
Time frame: Assessed up to 24 months from time of first dose
Duration of Response (DOR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months from time of first dose
Time to Response (TTR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months from time of first dose
Progression Free Survival (PFS)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months from time of first dose
Disease Control Rate (DCR)
Based on assessment of radiographic imaging per RECIST version 1.1
Time frame: Assessed up to 24 months from time of first dose
Plasma concentration (Cmax)
Maximum plasma concentration of ERAS-254 and trametinib
Time frame: Study Day 1 up to Day 29
Time to achieve Cmax (Tmax)
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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
...and 19 more locations
Time to achieve maximum plasma concentration of ERAS-254 and trametinib
Time frame: Study Day 1 up to Day 29
Area under the curve (AUC)
Area under the plasma concentration-time curve
Time frame: Study Day 1 up to Day 29
Overall survival
Survival Status
Time frame: Assessed up to 24 months from time of first dose