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

NCT07247110 | Recruiting Phase 1 FDA Drug

• 4 other identifiers: 4716-0012025-522495-84U1111-1323-3663MK-4701-001
• Study Type: interventional
• Target: 250
• Locations: 6 countries
• Sites: 15

Brief Summary

Researchers are looking for new ways to treat certain advanced or metastatic solid tumors. The goal of this study is to learn about the safety of MK-4716 and if people tolerate it when taken alone or with other treatments.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT)

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

  Up to approximately 28 days

• Number of Participants Who Experience an Adverse Event (AE)

  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.

  Up to approximately 5 years

• Number of Participants Who Discontinue Study Intervention Due to an AE

  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.

  Up to approximately 5 years

Secondary Outcomes (4)

• Area Under the Concentration-Time Curve (AUC) of MK-4716

  At designated timepoints (up to approximately 58 days)

• Maximum Plasma Concentration (Cmax) of MK-4716

  At designated timepoints (up to approximately 58 days)

• Trough Plasma Concentration (Ctrough) of MK-4716

  At designated timepoints (up to approximately 19 months)

• Half-Life (t1/2) of MK-4716

  At designated timepoints (up to approximately 58 days)

Study Arms (3)

MK-4716 Dose Escalation

EXPERIMENTAL

Participants receive MK-4716 at varying dose levels and schedules.

Drug: MK-4716

MK-4716 + Pembrolizumab

EXPERIMENTAL

Participants will receive MK-4716 + Pembrolizumab

Drug: MK-4716; Biological: Pembrolizumab

MK-4716 + Cetuximab

EXPERIMENTAL

Participants will receive MK-4716 + Cetuximab

Drug: MK-4716; Biological: Cetuximab

Interventions

MK-4716 DRUG

Oral administration

MK-4716 + Cetuximab; MK-4716 + Pembrolizumab; MK-4716 Dose Escalation

Pembrolizumab BIOLOGICAL

Intravenous administration

Also known as: Keytruda, MK-3475

MK-4716 + Pembrolizumab

Cetuximab BIOLOGICAL

Intravenous administration

MK-4716 + Cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (15)

Rutgers Cancer Institute of New Jersey ( Site 0052)

New Brunswick, New Jersey, 08903, United States

RECRUITING

NEXT Oncology ( Site 0051)

Irving, Texas, 75039, United States

RECRUITING

NEXT Virginia ( Site 0054)

Fairfax, Virginia, 22031, United States

RECRUITING

Blacktown Hospital ( Site 0455)

Sydney, New South Wales, 2148, Australia

RECRUITING

One Clinical Research ( Site 0454)

Nedlands, Western Australia, 6009, Australia

RECRUITING

Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)

Santiago, Region M. de Santiago, 8330073, Chile

RECRUITING

Bradfordhill ( Site 0102)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

Rambam Health Care Campus ( Site 0252)

Haifa, 3109601, Israel

RECRUITING

Rabin Medical Center ( Site 0253)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 0251)

Ramat Gan, 5265601, Israel

RECRUITING

Seoul National University Hospital ( Site 0501)

Seoul, 03080, South Korea

RECRUITING

Asan Medical Center ( Site 0502)

Seoul, 05505, South Korea

RECRUITING

Hospital General Universitari Vall d Hebron ( Site 0360)

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic de Barcelona ( Site 0362)

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz ( Site 0361)

Madrid, 28040, Spain

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Neoplasms

Interventions

pembrolizumab; Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 25, 2025
• Study Start: December 16, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IL (3); ES (3); US (3); CL (2); AU (2); KR (2)