MK-8294 for people with advanced metastatic solid tumors
A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK-8294 Monotherapy in Advanced Solid Tumors
This will try MK-8294, a targeted cancer drug, in people with advanced or metastatic solid tumors to find the highest dose that is safe and tolerable.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 67 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 5 sites (Chicago, Illinois and 4 other locations) |
| Trial ID | NCT07030712 on ClinicalTrials.gov |
What this trial studies
MK-8294 is an investigational targeted therapy being given to adults with advanced or metastatic solid tumors who have progressed after standard treatments. This Phase 1 dose-escalation trial enrolls patients with a range of tumor types to define safety, tolerability, dose-limiting toxicities, and the maximum tolerated dose. The study will collect adverse event and pharmacokinetic data and record any preliminary signals of anti-tumor activity. The trial is sponsored by Merck and includes clinical sites in the United States and Israel.
Who should consider this trial
Good fit: Adults with histologically or cytologically confirmed advanced or metastatic solid tumors (including certain head and neck, cervical, esophageal, triple-negative or HR+/HER2- breast, endometrial, and bladder cancers) who have exhausted or are intolerant of standard treatments are the intended participants.
Not a fit: Patients who still have effective standard treatment options, who require immediate therapy that cannot wait for trial screening, or who have poor organ function or uncontrolled infections are unlikely to benefit from or qualify for this study.
Why it matters
Potential benefit: If successful, MK-8294 could provide a new targeted treatment option that controls tumor growth for some patients with advanced solid tumors.
How similar studies have performed: Other targeted small-molecule therapies have shown benefit in select tumor types, but MK-8294 itself is in early-phase testing and its efficacy has not yet been demonstrated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 4 other locations
- Northwestern University ( Site 0101) — Chicago, Illinois, United States (Recruiting)
- Rambam Health Care Campus ( Site 0201) — Haifa, Israel (Recruiting)
- Sheba Medical Center ( Site 0200) — Ramat Gan, Israel (Recruiting)
- Radboudumc ( Site 0301) — Nijmegen, Gelderland, Netherlands (Recruiting)
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek - NKI-AVL ( Site 0300) — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.