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MK-4716 for Certain Solid Tumors

This study is testing a new drug called MK-4716, alone or with other treatments like pembrolizumab or cetuximab, for people with certain advanced solid tumors. Researchers want to understand how safe MK-4716 is and if people can tolerate it. To join, you must be at least 18 years old and have a specific type of solid tumor that has a KRAS alteration (a change in a gene). The study will look at how many participants experience side effects and how many stop treatment because of them. The study plans to enroll about 250 people, but its current status is unclear.

Study design
This is an interventional study planning to enroll about 250 participants. It is exploring the safety of MK-4716.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events for up to approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07247110

A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~250 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:MK-4716PembrolizumabCetuximab

At a glance

Recruiting sites
21 of 21 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT)
Measured over Up to approximately 28 days
+2 more outcomes measured

Conditions

Malignant Neoplasm

Explore related trials

Lung Non-Small Cell CarcinomaSolid NeoplasmGTPase KRas

Where it's being run

21 sites across 12 states
Region M. de Santiago3
Israel3
Spain3
Victoria2
Quebec2
South Korea2
New Jersey1
Texas1

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT)Up to approximately 28 days

    A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.

  • Number of Participants Who Experience an Adverse Event (AE)Up to approximately 4 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

  • Number of Participants Who Discontinue Study Intervention Due to an AEUp to approximately 4 years

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.