Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo targets tough cancers with RAS mutation

NCT ID NCT05907304

Disease control Sponsor: Erasca, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial is testing whether a combination of two drugs, naporafenib and trametinib, can shrink or control advanced solid tumors that have a specific genetic change called RAS Q61X. About 86 people whose cancer has not responded to standard treatments will receive the drugs. The main goals are to see if the combination is safe and whether it can shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
naporafenib (a Pan-Raf inhibitor) combined with trametinib (a MEK inhibitor)
What this could lead to
If it works, this could point toward a new treatment option for people with certain hard-to-treat cancers that have a RAS Q61X mutation.
What could go wrong
This is a very early (Phase 1) trial with only 86 participants, so it is not yet known if the combination is safe or effective. Many early-stage cancer drugs do not succeed in later trials.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

86 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Age ≥ 12 years 3. 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. 4. 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. 5. 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. 6. ECOG performance status 0, 1 or 2 7. Presence of at least 1 measurable lesion according to RECIST v1.1 8. Able to swallow oral medication. Exclusion Criteria: 1. Prior therapy with an ERK-, MEK-, RAF-, or RAS-inhibitor 2. Impairment of GI function or gastrointestinal (GI) disease that may significantly alter the absorption of study treatment (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection) 3. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndrome) 4. Corrected QT interval using Fridericia's formula (QTcF) at Screening \>450 ms based on triplicate average NOTE: criterion does not apply to patients with a right or left bundle branch block 5. LVEF \<50% 6. All primary CNS tumors 7. Symptomatic CNS metastases that are neurologically unstable. Patients with controlled CNS metastases are eligible. 8. Patients receiving treatment with medications that are known to be strong inhibitors and/or inducers of cytochrome P450 (CYP)3A; substrates of CYP2C8, CYP2C9, and CYP3A with a narrow therapeutic index and sensitive substrates of CYP3A; 9. Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced or metastatic solid tumors are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

colorectal neoplasm melanoma metastatic malignant neoplasm non-small cell lung carcinoma pancreatic neoplasm Thyroid Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced or metastatic solid tumors

Contacts and locations

Locations

  • Beatson West of Scotland Cancer Center

    Glasgow, United Kingdom

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4E6, Canada

  • Comprehensive Cancer Center of Nevada (CCCN)

    Las Vegas, Nevada, 89169, United States

  • Cross Cancer Institute- Alberta Health Services (AHS)

    Edmonton, Alberta, T6G 1Z2, Canada

  • Emory University School of Medicine

    Atlanta, Georgia, 30322, United States

  • Florida Cancer Specialists - Sarasota

    Sarasota, Florida, 34232, United States

  • Florida Cancer Specialists - St. Petersburg

    St. Petersburg, Florida, 33705, United States

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Inje University Haeundae Paik Hospital

    Busan, Busan Gwang'yeogsi, 48108, South Korea

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Linear Clinical Research, LTD

    Perth, Australia

  • London Regional Cancer Center

    London, Ontario, Canada

  • Macquarie University

    Macquarie Park, New South Wales, Australia

  • NEXT Virginia

    Fairfax, Virginia, 22031, United States

  • National Cancer Center

    Goyang-si, South Korea

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9, Canada

  • SCRI Oncology Partners (formerly Tennessee Oncology)

    Nashville, Tennessee, 37203, United States

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi, 06351, South Korea

  • Sarah Cannon Research Institute - HCA Healthcare

    City of London, London, W1G 6AD, United Kingdom

  • Seoul National University Hospital

    Seoul, South Korea

  • Seoul National University Hospital Bundang

    Gyeonggi-do, South Korea

  • St. Vincent's Hospital

    Melbourne, Victoria, Australia

  • The Catholic University Hospital

    Seoul, South Korea

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Yale Cancer Center

    New Haven, Connecticut, 06510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.