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New treatment option for Metastatic Neoplasm
Official title A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)
ClinicalTrials.gov ID: NCT07030712
What this study is testing
What is MK-8294?
MK-8294 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic neoplasm.
Also referred to as DAB014236.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main 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...
- 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...
- Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable
You likely can't join if
- 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...
- Has ongoing radiation-related toxicities, requiring corticosteroids
- Has known additional malignancy that is progressing or has required active treatment within the past 2 years
See the full eligibility criteria
- The main 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...
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Houston, Texas, United States
- Haifa, Israel
- Ramat Gan, Israel
- Nijmegen, Gelderland, Netherlands
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Houston, Texas, United States; Haifa, Israel; Ramat Gan, Israel; Nijmegen, Gelderland, Netherlands; Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.