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

NCT07247110
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
250
clinicaltrials.gov
Lead sponsor
Merck Sharp & Dohme LLC
clinicaltrials.gov
Start date
2025-12-16
clinicaltrials.gov
Number of sites
11
clinicaltrials.gov

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.
clinicaltrials.gov
Short title
A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
clinicaltrials.gov
Official title
A Phase 1, Open-Label, Multicenter Study to Assess Safety, Tolerability, Pharmacokinetics, and Efficacy of MK-4716 as Monotherapy and as Part of Combination Therapy in Participants With KRAS-Altered Advanced or Metastatic Solid Tumors
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2030-12-01
clinicaltrials.gov
First posted
2025-11-25
clinicaltrials.gov
Registry last updated
2026-08-28
clinicaltrials.gov
Primary completion date
2030-12-01
clinicaltrials.gov
Start date
2025-12-16
clinicaltrials.gov

Participants
250
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
250
clinicaltrials.gov
Protocol amendments
3
clinicaltrials.gov
Number of sites
11
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Merck Sharp & Dohme LLC
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07247110
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07247110
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

    Timeframe: 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.

  2. Number of Participants Who Experience an Adverse Event (AE)

    Timeframe: 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.

  3. Number of Participants Who Discontinue Study Intervention Due to an AE

    Timeframe: 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.

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

    Timeframe: At designated timepoints (up to approximately 58 days)

    Blood samples will be collected to determine the AUC of MK-4716.

  2. Maximum Plasma Concentration (Cmax) of MK-4716

    Timeframe: At designated timepoints (up to approximately 58 days)

    Blood samples will be collected to estimate Cmax of MK-4716.

  3. Trough Plasma Concentration (Ctrough) of MK-4716

    Timeframe: At designated timepoints (up to approximately 19 months)

    Blood samples will be collected to determine the Ctrough of MK-4716.

  4. Half-Life (t1/2) of MK-4716

    Timeframe: At designated timepoints (up to approximately 58 days)

    Blood samples will be collected to determine the t1/2 of MK-4716.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
Sources for eligibility
clinicaltrials.gov

  • Rutgers Cancer Institute of New Jersey ( Site 0052)New Brunswick, United StatesRecruiting
  • NEXT Oncology ( Site 0051)Irving, United StatesRecruiting
  • NEXT Virginia ( Site 0054)Fairfax, United StatesRecruiting
  • One Clinical Research ( Site 0454)Nedlands, AustraliaRecruiting
  • Rambam Health Care Campus ( Site 0252)Haifa, IsraelRecruiting
  • Rabin Medical Center ( Site 0253)Petah Tikva, IsraelRecruiting
  • Sheba Medical Center ( Site 0251)Ramat Gan, IsraelRecruiting
  • Asan Medical Center ( Site 0502)Seoul, South KoreaRecruiting
  • Hospital General Universitari Vall d Hebron ( Site 0360)Barcelona, SpainRecruiting
  • Hospital Clinic de Barcelona ( Site 0362)Barcelona, SpainRecruiting
  • Hospital Universitario Fundacion Jimenez Diaz ( Site 0361)Madrid, SpainRecruiting
Sources for sites
clinicaltrials.gov

  • MK-4701-001
  • 2025
  • U1111-1323-3663
  • 2025-522495-84
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (1)

Targets (2)