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Kinase Inhibitor

Naporafenib + Trametinib for Solid Tumors (SEACRAFT-1 Trial)

Phase 1

Recruiting

Research Sponsored by Erasca, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed up to 24 months from time of first dose

Awards & highlights

SEACRAFT-1 Trial Summary

This trial tests the safety & effectiveness of a drug combo for RAS Q61X solid tumors. It also assesses how the body processes the drugs.

Who is the study for?

This trial is for patients aged 12 or older with advanced solid tumors containing a specific mutation (RAS Q61X). They must have at least one measurable tumor, be able to take oral medication, and not have standard treatment options available. Patients who've had certain prior treatments or suffer from conditions affecting drug absorption, heart function, or eye health are excluded.Check my eligibility

What is being tested?

The study tests the effectiveness and safety of combining two drugs: Naporafenib and Trametinib in treating solid tumors with RAS Q61X mutations. It also aims to understand how these drugs behave in the body when taken together by patients with this genetic alteration.See study design

What are the potential side effects?

While the exact side effects aren't listed here, similar medications often cause digestive issues, skin reactions, changes in blood pressure or heart rhythm, vision problems, fatigue and may affect liver function. The trial will closely monitor participants for any adverse reactions.

SEACRAFT-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed up to 24 months from time of first dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed up to 24 months from time of first dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed up to 24 months from time of first dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors

Secondary outcome measures

Adverse Events

Area under the curve (AUC)

Disease Control Rate (DCR)

+6 more

Other outcome measures

Disease Control Rate (DCR) for CNS disease in participants

Duration of Response (DOR) for CNS disease in participants

Overall Response Rate (ORR) for CNS disease in participants

+1 more

SEACRAFT-1 Trial Design

1Treatment groups

Experimental Treatment

Group I: Naporafenib + TrametinibExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trametinib

2014

Completed Phase 2

~1550

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Erasca, Inc.Lead Sponsor

7 Previous Clinical Trials

1,048 Total Patients Enrolled

Joyce Antal, MSStudy DirectorClinical Development

Media Library

Naporafenib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05907304 — Phase 1

Solid Tumors Research Study Groups: Naporafenib + Trametinib

Solid Tumors Clinical Trial 2023: Naporafenib Highlights & Side Effects. Trial Name: NCT05907304 — Phase 1

Naporafenib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05907304 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this clinical trial restricted to individuals older than fifty-five?

"The parameters surrounding enrolment in this study specify that patients must be aged between 12 and 99."

Answered by AI

Has the federal government sanctioned Naporafenib + Trametinib for clinical use?

"There is limited evidence supporting the safety and efficacy of Naporafenib + Trametinib, thus this drug combination received a score of 1."

Answered by AI

Are there any opportunities for volunteers to join this investigation?

"According to clinicaltrials.gov, the applications for this trial are no longer being accepted as it has been edited most recently on July 24th 2023. Despite that, there are still 37 other studies with open enrollment right now."

Answered by AI

Do I meet the qualifications necessary to partake in this investigation?

"This clinical trial is seeking 115 individuals, ranging from 12 to 99 years old, with solid tumours. All participants must be willing and able to provide written informed consent; have an ECOG performance status of 0, 1 or 2; present a RAS Q61X mutation (in either blood or tissue); have at least one measurable lesion according to RECIST v1.1; and demonstrate the ability to swallow oral medication. Furthermore, those who are intolerant of standard therapy or decline it can also join this study provided that the investigator deems them appropriate for enrolment. Lastly, archival tumor tissue collected within 5 years prior to"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05907304.