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New drug MK-4716 targets KRAS cancers in early trial

NCT ID NCT07247110

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 6 times

Summary

This early-stage trial is testing an experimental drug called MK-4716, alone or combined with other cancer drugs, in people with advanced solid tumors that have a KRAS mutation. The main goal is to see if the drug is safe and tolerable. About 250 participants will be enrolled.

What this could mean

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

Active substance
MK-4716 (an experimental drug), pembrolizumab (Keytruda), and cetuximab
What this could lead to
If successful, this could point toward a new treatment option for people with advanced cancers that have a KRAS mutation.
What could go wrong
This is an early Phase 1 trial with only 250 participants, so it is primarily testing safety. The drug may not work or could have side effects.

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

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2030

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

18 years and older

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.

Inclusion Criteria: * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumor * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has received at least 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease * Arm MK-4716 + Pembrolizumab: Has a confirmed diagnosis of metastatic non-small cell lung cancer * Arm MK-4716 + Pembrolizumab: Must demonstrate presence of KRAS alteration * Arm MK-4716 + Pembrolizumab: Must be untreated * Has measurable disease * Has the ability to swallow and retain oral medication Exclusion Criteria: * Arm MK-4716 + Pembrolizumab: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Arm MK-4716 + Pembrolizumab: Has received any prior immunotherapy and was discontinued from that treatment * Arm MK-4716 + Pembrolizumab: Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * History of human immunodeficiency virus infection * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years * Has a known active central nervous system metastases and/or carcinomatous meningitis * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has Hepatitis B or Hepatitis C virus infection * History of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications

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Conditions

The condition(s) this trial relates to.

cancer neoplasm non-small cell lung carcinoma

As listed by the trial registrant

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

Malignant neoplasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    21 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Asan Medical Center ( Site 0502)

    RECRUITING

    Seoul, 05505, South Korea

  • Blacktown Hospital ( Site 0455)

    RECRUITING

    Sydney, New South Wales, 2148, Australia

  • Bradfordhill ( Site 0102)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • Centre Hospitalier de l'Université de Montréal ( Site 0003)

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

  • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0002)

    RECRUITING

    Québec, Quebec, G1J 1Z4, Canada

  • FALP-UIDO ( Site 0101)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Hospital Clinic de Barcelona ( Site 0362)

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitari Vall d Hebron ( Site 0360)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Fundacion Jimenez Diaz ( Site 0361)

    RECRUITING

    Madrid, 28040, Spain

  • Monash Health ( Site 0452)

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • NEXT Oncology ( Site 0051)

    RECRUITING

    Irving, Texas, 75039, United States

  • NEXT Virginia ( Site 0054)

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • One Clinical Research ( Site 0454)

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)

    RECRUITING

    Santiago, Region M. de Santiago, 8330073, Chile

  • Princess Margaret Cancer Centre ( Site 0001)

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • Rabin Medical Center ( Site 0253)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Rambam Health Care Campus ( Site 0252)

    RECRUITING

    Haifa, 3109601, Israel

  • Rutgers Cancer Institute of New Jersey ( Site 0052)

    RECRUITING

    New Brunswick, New Jersey, 08903, United States

  • Seoul National University Hospital ( Site 0501)

    RECRUITING

    Seoul, 03080, South Korea

  • Sheba Medical Center ( Site 0251)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • The Alfred Hospital ( Site 0453)

    RECRUITING

    Melbourne, Victoria, 3004, Australia

More trials for these conditions

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