A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)

Официальное название

A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK-8294 Monotherapy in Advanced Solid Tumors

Обзор

MK-8294, the study medicine, is a type of targeted therapy designed to treat certain solid tumors. The main goals of this study are to learn about the safety of MK-8294 and if people can tolerate it and find the highest dose level of MK-8294 that people can tolerate.

Вмешательства

• Препарат MK-8294
  30 µg via intravenous (IV) infusion
• Препарат MK-8294
  100 µg via intravenous (IV) infusion
• Препарат MK-8294
  300 µg via intravenous (IV) infusion
• Препарат MK-8294
  1 mg via intravenous (IV) infusion
• Препарат MK-8294
  3 mg via intravenous (IV) infusion
• Препарат MK-8294
  10 mg via intravenous (IV) infusion
• Препарат MK-8294
  30 mg via intravenous (IV) infusion
• Препарат MK-8294
  70 mg via intravenous (IV) infusion
• Другое CD8 PET Tracer
  IV Infusion

Первичные конечные точки

• Number of participants who experience one or more dose-limiting toxicities (DLTs) [Срок оценки: Up to approximately 35 days]
• Number of Participants Who Experience an Adverse Event (AE) [Срок оценки: Up to approximately 2 years]
• Number of Participants Who Discontinue Study Intervention Due to an AE [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (7)

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 2 years]
• Area Under the Plasma Concentration-Time Curve (AUC) of MK-8294 [Срок оценки: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)]
• Minimum Concentration (Cmin) of MK-8294 [Срок оценки: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)]
• Maximum Plasma Concentration (Cmax) of MK-8294 [Срок оценки: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)]
• Time to Maximum Plasma Concentration (Tmax) of MK-8294 [Срок оценки: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)]
• Incidence of Antidrug Antibodies (ADA) to MK-8294 [Срок оценки: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)]
• Titer of ADA to MK-8294 [Срок оценки: Predose and at designated timepoints in each cycle for up to approximately 2 years (each cycle = 3 weeks)]

Критерии участия

Критерии включения

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

• Has histologically or cytologically confirmed advanced/metastatic solid tumor; including head and neck squamous cell carcinoma, cervical squamous cell carcinoma, esophageal squamous cell carcinoma, breast cancer (triple negative breast cancer, Estrogen Receptor \[ER\]/progesterone receptor +, human epidermal growth factor receptor 2 negative \[HER2-\]), endometrial, and bladder cancer by pathology report and have previously failed standard treatment, lack standard treatment options, or are intolerant to standard treatment
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
• Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Критерии исключения

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

• HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Has a history of New York Heart Association Class II or greater heart failure
• Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher immune-related Adverse Event (irAE) (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
• Has ongoing radiation-related toxicities, requiring corticosteroids
• 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
• Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid)
• Has active infection requiring systemic therapy
• Has history of stem cell/solid organ transplant
• Has not adequately recovered from major surgery or have ongoing surgical complications

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Northwestern University ( Site 0101) — Chicago
• Houston Methodist Hospital ( Site 0103) — Houston

Израиль · 2 центра

• Rambam Health Care Campus ( Site 0201) — Haifa
• Sheba Medical Center ( Site 0200) — Ramat Gan

Нидерланды · 2 центра

• Radboudumc ( Site 0301) — Nijmegen
• Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0300) — Amsterdam

Идентификаторы

NCT: NCT07030712 · 8294-001 · 2024-516870-31-00 · U1111-1311-2807 · MK-8294-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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