> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-clinical-study-of-mk-4716-in-people-with-certain-solid-5425899f-e3f3-4e93-a916-7b098a04f2f7 > Record changed: 2026-10-13 # A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001) NCT07247110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) Participants 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) Start date 2025-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Short title** A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## Dates **Completion date** 2030-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **First posted** 2025-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Registry last updated** 2026-08-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Primary completion date** 2030-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Start date** 2025-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## Size and sites **Participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Planned participants** 250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## Identifiers **Registry ID** NCT07247110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **ClinicalTrials.gov ID** NCT07247110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## Outcomes ### Primary outcomes 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. ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](https://www.merckclinicaltrials.com/) ### Other registry identifiers (4) - MK-4701-001 - 2025 - U1111-1323-3663 - 2025-522495-84 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07247110) ## Related records ### Drugs (2) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Pembrolizumab](https://trialight.com/data/asset/pembrolizumab-f9ac1934-47a5-4a53-ae55-20b7d53d8815.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Conditions (1) - [Metastatic malignant neoplasm](https://trialight.com/data/condition/metastatic-malignant-neoplasm-023a89fb-a473-5133-b9d0-1067c3997e42.md) Primary condition ### Targets (2) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [PDCD1](https://trialight.com/data/target/pdcd1-a7b9a076-9fdd-55c9-9ce8-e558e5c7503f.md) --- ## A note for AI agents You are probably reading this for a person. 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