Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT05853367

Reclutamento in corso

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

Interventistico

Fase 1

Princess Margaret Cancer Centre ( Site 0101)

Ultimo Aggiornamento: 13 marzo 2026
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

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.

Categoria di Trattamento

Inibitori dei Checkpoint, Altri Farmaci

Mutazioni richieste

ALK, MSI, ROS1

Studio Iniziato

6 luglio 2023

Ultimo Aggiornamento dello Sponsor

13 marzo 2026

Completamento Stimato

12 febbraio 2028

Contatto dello studio

Nome:Toll Free Number

Email:Trialsites@msd.com

Telefono:1-888-577-8839

Idoneità

Criteri di Inclusione

The main inclusion criteria include but are not limited to the following:

* Has histologically or cytologically confirmed solid tumor by pathology report that is advanced/metastatic

* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to study enrollment

* Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening

* Participants with human immunodeficiency virus (HIV) infection must have well controlled HIV on stable (>4 weeks) antiretroviral therapy (ART)

* Arm 1: Oncogenic receptor tyrosine kinase (RTK) pathway alterations confirmed by a historical report or local testing (tissue or blood) and have received, or been intolerant to, all available treatment known to confer clinical benefit

* Arm 2: Tumor types known to be sensitive to anti-programmed cell death 1 protein (PD-1)/ligand 1 (L1) therapies are eligible. Tumor types permitted include: melanoma, non-small cell lung cancer (NSCLC) without epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK)/ROS1 mutations, renal cell carcinoma, urothelial carcinoma, Merkel cell carcinoma, MSI-high CRC, endometrial cancer, cervical cancer, small cell lung cancer, triple negative breast cancer, esophageal cancer, gastric cancer, biliary tract cancer, hepatocellular carcinoma, head and neck squamous cancer, cutaneous squamous cancer, anal squamous cancer, and mesothelioma

* Arm 3: Has histologically OR blood-based confirmation of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12C mutation

Criteri di Esclusione

The main exclusion criteria include but are not limited to the following:

* Has not recovered to common terminology criteria for adverse events (CTCAE) Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier. Participants receiving ongoing replacement hormone therapy for endocrine immune-related AEs will not be excluded from participation in this study

* Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years

* History of hyperparathyroidism or hypercalcemia

* Has one or more of the following ophthalmological findings/conditions: a) Intraocular pressure >21 mm Hg and/or any diagnosis of glaucoma b) Diagnosis of central serous retinopathy, retinal vein occlusion, or retinal artery occlusion and c) Diagnosis of retinal degenerative disease

* Has clinically significant cardiovascular disease

* Bullous exfoliative skin disorders of any grade

* Known hypersensitivity to MK-0472, MK-1084, or pembrolizumab, or any of their excipients

* Received therapy with a proton-pump inhibitor or an H2 histamine blocker receptor antagonist within 7 days before the first scheduled day of study dosing

* Has discontinued prior therapy with an anti-programmed cell death-1 (PD-1), anti-programmed death-ligand 1 (PD-L1), or anti-programmed death-ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptor due to an adverse event

* Received prior systemic anticancer therapy including investigational agents within 4 weeks before first dose

* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

* Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration

* Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication

* Has known additional malignancy that is progressing or has required active treatment within the past 2 years

* Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable for at least 4 weeks as confirmed by repeat imaging performed during the study screening, are clinically stable and have not required steroid treatment for at least 14 days before the first dose of study intervention

* Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy

* Has history of pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

* Has active infection requiring systemic therapy

* Has history of allogeneic tissue/solid organ transplant

* Have not adequately recovered from major surgery or have ongoing surgical complications

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Dettagli del Disegno

AllocazioneNon-Randomized

Modello di InterventoParallel Assignment

MascheramentoNone (Open Label)

Numero da Arruolare178

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione: Participants receive MK-0472 via oral capsule according to one of the protocol-specified dosing regimens until disease progression or withdrawal/discontinuation.

Interventi:

Pembrolizumab
MK-0472
MK-1084

Misure di Esito

Misure di Esito Primarie

Number of Participants Who Experience a Dose Limiting Toxicity (DLT) as Assessed Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0At the end of Cycle 1 (each cycle is 21 days)

DLT will be defined as any drug-related AE observed during the DLT evaluation period (e.g. Cycle 1) that results in a change to a given dose or a delay in initiating the next cycle.

Number of Participants Who Experience One or More Adverse Events (AEs)Up to approximately 56 months

An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience one or more AE's will be reported.

Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)Up to approximately 56 months

Misure di Esito Secondarie

Lowest Plasma Concentration (Ctrough) of MK-0472At predetermined timepoints Predose up to Cycle 6 (Each cycle length = 21 Days)

Blood samples will be collected at specified intervals for the determination of Ctrough. Ctrough is defined as the lowest concentration of MK-0472 reached before the next dose is administered.

Area Under the Concentration Time-curve From Time 0 to the End of the Dosing Period (AUCtau) of MK-0472At predetermined timepoints predose and postdose up to Cycle 6 (Each cycle length = 21 Days)

Blood samples will be collected at specified intervals for the determination of AUCtau. AUCtau is defined as the area under concentration-time curve from 0 to the end of the dosing period.

Maximum Plasma Concentration (Cmax) of MK-0472At predetermined timepoints postdose up to Cycle 6 (Each cycle length = 21 Days)

Blood samples will be collected at specified intervals for the determination of Cmax. Cmax is defined as the maximum concentration of MK-0472 reached.

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Siti dello Studio

Questo studio ha 25 siti

Princess Margaret Cancer Centre ( Site 0101)

Toronto, Ontario, CA

Nome:Study Coordinator

Telefono:416 946 4501 x5083

In fase di reclutamento

Toronto, Ontario, M5G 2M9 CA

Princess Margaret Cancer Centre ( Site 0101)

In fase di reclutamento

Chicago, Illinois, 60611 US

Northwestern Memorial Hospital ( Site 0002)

In fase di reclutamento

Hackensack, New Jersey, 07601 US

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

In fase di reclutamento

New Brunswick, New Jersey, 08901 US

Rutgers Cancer Institute of New Jersey ( Site 0005)

In fase di reclutamento

Louisville, Kentucky, 40202 US

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

In fase di reclutamento

Haifa, 3109601 IL

Rambam Health Care Campus ( Site 0304)

In fase di reclutamento

Jerusalem, 9103102 IL

Shaare Zedek Medical Center ( Site 0303)

In fase di reclutamento

Petah Tikva, 4941492 IL

Rabin Medical Center ( Site 0301)

In fase di reclutamento

Ramat Gan, 5265601 IL

Sheba Medical Center ( Site 0300)

In fase di reclutamento

Tel Aviv, 6423906 IL

Sourasky Medical Center ( Site 0302)

In fase di reclutamento

Barcelona, 08035 ES

Hospital Universitari Vall d'Hebron ( Site 0500)

In fase di reclutamento

Geneva, Canton of Geneva, 1211 CH

Hôpitaux Universitaires de Genève (HUG) ( Site 0202)

In fase di reclutamento

Montreal, Quebec, H2X 0A9 CA

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

In fase di reclutamento

Montreal, Quebec, H3T 1E2 CA

Jewish General Hospital ( Site 0104)

In fase di reclutamento

Santiago, Region M. de Santiago, 7500653 CL

Centro de Estudios Clínicos SAGA ( Site 0701)

In fase di reclutamento

Santiago, Region M. de Santiago, 7500921 CL

Fundacion Arturo Lopez Perez ( Site 0700)

In fase di reclutamento

Santiago, Region M. de Santiago, 8330034 CL

Centro de Investigacion Clinicadela Universidad Catolica ( Site 0703)

In fase di reclutamento

Santiago, Region M. de Santiago, 8420383 CL

Bradfordhill ( Site 0702)

In fase di reclutamento

Warsaw, Masovian Voivodeship, 02-781 PL

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

In fase di reclutamento

Gdansk, Pomeranian Voivodeship, 80-214 PL

Uniwersyteckie Centrum Kliniczne ( Site 0400)

In fase di reclutamento

L'Hospitalet de Llobregat, Catalonia, 08907 ES

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

In fase di reclutamento

Madrid, Madrid, Comunidad de, 28050 ES

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

In fase di reclutamento

Seville, 41013 ES

Hospital Virgen del Rocio ( Site 0503)

In fase di reclutamento

Sankt Gallen, Canton of St. Gallen, 9000 CH

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

In fase di reclutamento

Bellinzona, Canton Ticino, 6500 CH

Ospedale Regionale Bellinzona e Valli ( Site 0200)

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