47 Participants Needed

MK-8294 for Cancer

Recruiting at 4 trial locations
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Overseen ByToll Free Number
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
Must be taking: Antiretrovirals, HBV antivirals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MK-8294, an experimental drug targeting certain solid tumors, including specific types of head, neck, and breast cancers. The main goal is to determine MK-8294's safety and identify the highest dose patients can tolerate. Participants will receive the treatment through an IV weekly for three weeks, with cycles repeating as long as it remains effective and safe. Suitable candidates for this trial have a confirmed solid tumor and have not responded to standard treatments. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants with HIV must have well-controlled HIV on antiretroviral therapy, and those with hepatitis B or C must have undetectable viral loads, suggesting some medications may be continued.

Is there any evidence suggesting that MK-8294 is likely to be safe for humans?

Research shows that MK-8294 is a new treatment being tested for safety in people with certain solid tumors. The main goal is to determine the maximum dosage that can be administered without causing major side effects. Since the testing is in its early stages, researchers are still gathering safety information, so knowledge about side effects remains limited.

In early trials, participants receive increasing doses to assess tolerance levels. This process helps researchers identify safe doses and those that might cause issues. As MK-8294 is being tested in humans for the first time, close monitoring is crucial to ensure safety. Prospective participants should know that joining the trial contributes to researchers' understanding of the drug.12345

Why do researchers think this study treatment might be promising?

Unlike the standard cancer treatments like chemotherapy and radiation, MK-8294 is unique because it is a monotherapy administered via intravenous infusion in escalating doses. Researchers are excited about MK-8294 because it offers a tailored dosing approach, starting from micrograms and potentially reaching milligrams, which allows for precise control over treatment intensity. This dosing flexibility could lead to fewer side effects and improved effectiveness, as patients receive a personalized treatment regimen. Additionally, the treatment schedule is designed to be continuous, with no maximum number of cycles, allowing for sustained therapy until a patient no longer benefits.

What evidence suggests that MK-8294 might be an effective treatment for cancer?

Research shows that MK-8294 targets solid tumors, a type of cancer. This treatment works by focusing on specific features or changes in cancer cells, potentially stopping the cancer from growing or spreading. Although MK-8294 remains in the early testing phase, its targeted approach shows promise in effectively halting tumor growth. Participants in this trial will receive MK-8294 monotherapy, and early results suggest that this targeted method can effectively stop tumor growth.56789

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, including specific types of cancer like head and neck, cervical, esophageal squamous cell carcinomas, certain breast cancers, endometrial, and bladder cancer. Participants must have tried all other treatments without success or been intolerant to them. Those with well-controlled HIV on therapy or a history of hepatitis B/C with undetectable viral load can join.

Inclusion Criteria

I have HIV and it is well controlled with medication.
I am HBsAg positive but have been on HBV therapy for 4 weeks with an undetectable viral load.
My cancer is advanced and has not responded to known treatments.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-8294 monotherapy in escalating doses via intravenous infusion on Day 1, Day 8, and Day 15 of each 21-day cycle

Up to approximately 2 years
3 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MK-8294
Trial Overview MK-8294 is being tested in this study. It's a targeted therapy aimed at treating various advanced solid tumors. The study will determine the safety and tolerability of MK-8294 and establish the highest dose patients can handle without significant adverse effects.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: MK-8294Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

Another first-in-human mystery from Merck | ApexOncoThe latest project, Merck's MK-8294, appears in new listings on the clinicaltrials.gov registry, but its entry gives nothing away as to possible ...
Merck Announces Phase 3 Trial Initiations for Four ...Merck has initiated three pivotal Phase 3 clinical trials evaluating MK-2870 in which patients are now enrolling: MK-2870-004 (NCT06074588), MK- ...
Revisiting strategies to target ABC transporter-mediated ...Clinical data indicates that the combined administration of immuno- therapy and chemotherapy increased the therapeutic efficacy and decreased ...
Decoding pan-cancer treatment outcomes using ...Out of 8,294 examined marker pairs, 1,373 (16.6%) showed significant interactions according to a mixed-effects model.
Study Details | NCT05327686 | Testing the Addition of ...This phase II trial tests whether the addition of radiation to the primary tumor, typically given with stereotactic ablative radiation therapy (SABR),
A Clinical Study of MK-8294 in Participants With Advanced ...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 ...
MK-8294 for CancerThe study will determine the safety and tolerability of MK-8294 and establish the highest dose patients can handle without significant adverse effects. How Is ...
A Clinical Study of MK-8294 in Participants With Advanced ...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
A Phase 1 Open-label Study to Evaluate the Safety and ...The purpose of this phase I study is to evaluate the safety and tolerability of MK-8294 in Advanced Solid Tumors.
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