RecruitingPhase 1NCT05853367

Study of MK-0472 in Participants With Advanced/Metastatic Solid Tumors (MK-0472-001)

A Phase 1/1b Open-label, Multicenter Clinical Study of MK-0472 as Monotherapy and Combination Therapy in Participants With Advanced/Metastatic Solid Tumors.

Sponsor

Merck Sharp & Dohme LLC

Enrollment

178 participants

Start Date

Jul 6, 2023

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumors Metastatic Solid Tumors

Summary

The purpose of this study is to assess the efficacy, safety, and tolerability of MK-0472 administered as monotherapy and in combination with pembrolizumab (MK-3475) or MK-1084 in participants with histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumors.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called MK-0472 in people with advanced or metastatic solid tumors (cancers that have spread). It is an early-phase trial to assess safety, dosing, and early signs of effectiveness across different cancer types. **You may be eligible if...** - You have a solid tumor cancer that is advanced or has spread, confirmed by biopsy - You have received standard treatments that are no longer working, or there are no standard treatments available - You have well-controlled HIV, hepatitis B, or hepatitis C (if applicable) - Your cancer has specific genetic changes (such as a certain kinase mutation or is a type known to respond to immunotherapy, like melanoma or lung cancer) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active autoimmune disease or have received live vaccines recently - You have significant heart, liver, or kidney problems - You have received other investigational treatments recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMK-0472

Oral Administration

BIOLOGICALPembrolizumab

IV infusion

DRUGMK-1084

Oral Administration

Locations(25)

Northwestern Memorial Hospital ( Site 0002)

Chicago, Illinois, United States

The University of Louisville, James Graham Brown Cancer Center ( Site 0004)

Louisville, Kentucky, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0001)

Hackensack, New Jersey, United States

Rutgers Cancer Institute of New Jersey ( Site 0005)

New Brunswick, New Jersey, United States

Princess Margaret Cancer Centre ( Site 0101)

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0100)

Montreal, Quebec, Canada

Jewish General Hospital ( Site 0104)

Montreal, Quebec, Canada

Centro de Estudios Clínicos SAGA ( Site 0701)

Santiago, Region M. de Santiago, Chile

Fundacion Arturo Lopez Perez ( Site 0700)

Santiago, Region M. de Santiago, Chile

Centro de Investigacion Clinicadela Universidad Catolica ( Site 0703)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0702)

Santiago, Region M. de Santiago, Chile

Rambam Health Care Campus ( Site 0304)

Haifa, Israel

Shaare Zedek Medical Center ( Site 0303)

Jerusalem, Israel

Rabin Medical Center ( Site 0301)

Petah Tikva, Israel

Sheba Medical Center ( Site 0300)

Ramat Gan, Israel

Sourasky Medical Center ( Site 0302)

Tel Aviv, Israel

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 0401)

Warsaw, Masovian Voivodeship, Poland

Uniwersyteckie Centrum Kliniczne ( Site 0400)

Gdansk, Pomeranian Voivodeship, Poland

Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 0501)

L'Hospitalet de Llobregat, Catalonia, Spain

Centro Integral Oncologico Clara Campal-Hospital HM Universitario Sanchinarro-START Madrid, ( Site 0504)

Madrid, Madrid, Comunidad de, Spain

Hospital Universitari Vall d'Hebron ( Site 0500)

Barcelona, Spain

Hospital Virgen del Rocio ( Site 0503)

Seville, Spain

Hôpitaux Universitaires de Genève (HUG) ( Site 0202)

Geneva, Canton of Geneva, Switzerland

Cantonal Hospital St.Gallen-Oncology & Hematology ( Site 0201)

Sankt Gallen, Canton of St. Gallen, Switzerland

Ospedale Regionale Bellinzona e Valli ( Site 0200)

Bellinzona, Canton Ticino, Switzerland

View Full Details on ClinicalTrials.gov

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