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

Active:	Yes
Cancer Type:	Solid Tumor Unknown Primary	NCT ID:	NCT05907304
Trial Phases:	Phase I	Protocol IDs:	ERAS-254-01 (primary) NCI-2024-00013
Eligibility:	12 - 99 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Erasca, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05907304

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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