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

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Secondary outcome measures (7)

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 2 centers

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

Israel · 2 centers

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

Netherlands · 2 centers

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

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗