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Trametinib

Naporafenib

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Naporafenib (ERAS-254) 200 mg twice daily (BID) Trametinib 1 mg once daily (QD)

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.

Erasca Clinical Team

Joyce Antal, MS

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.

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

An Open-label Study to Assess the Safety and Efficacy of Naporafenib (ERAS-254) Administered With Trametinib in Previously Treated Patients With Locally Advanced Unresectable or Metastatic Solid Tumor Malignancies With RAS Q61X Mutations

Based on Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM)

DUSP6: changes from baseline in the expression of DUSP-6 mRNA in blood, a marker of MAPK pathway Inhibition.

Based on assessment of Objective response rate (ORR) per RECIST version 1.1

Incidence and severity of treatment-emergent AEs and serious AEs

Based on assessment of radiographic imaging per RECIST version 1.1

Maximum plasma concentration of ERAS-254 and trametinib

Time to achieve maximum plasma concentration of ERAS-254 and trametinib

Area under the plasma concentration-time curve

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations	NCT05907304	Advanced or Met...	Naporafenib Trametinib	12 Years - 99 Years	Erasca, Inc.
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations	NCT05907304	Advanced or Met...	Naporafenib Trametinib	12 Years - 99 Years	Erasca, Inc.
A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations	NCT05907304	Advanced or Met...	Naporafenib Trametinib	12 Years - 99 Years	Erasca, Inc.

Spots Global Cancer Trial Database for colorectal cancer (cohort full)