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A Clinical Trial of MK-6255 to Treat Endometrial and Ovarian Cancer (MK-6255-001)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat advanced and recurrent endometrial cancer (EC) and ovarian cancer (OC). Advanced means the cancer has spread to other parts of the body and cannot be removed with surgery. Recurrent means the cancer came back after treatment. MK-6255 is a trial medicine designed to treat advanced and recurrent EC and OC. This trial is the first time that researchers will give MK-6255 to people. The goals of this trial are to learn about: * The safety of MK-6255 and if participants tolerate it. Tolerate means participants will receive the trial medicine unless they need to stop it due to health problems. * What happens to different dose levels (amounts) of MK-6255 in the body over time.
Official title: A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK-6255 Monotherapy in Advanced Solid Tumors
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-11-13
Completion Date
2031-07-07
Last Updated
2026-10-13
Healthy Volunteers
No
Conditions
Interventions
MK-6255
During initial dose escalation, participants will receive MK-6255 one weekly (QW). During Dose Interval Extension, participants will receive target doses every 3 weeks (Q3W).
CD8 PET Tracer
Participants may receive an optional CD8 PET tracer for exploratory imaging assessments.
Acetaminophen
Participants will receive acetaminophen (or similar antipyretic) as premedication.
Diphenhydramine
Participants will receive diphenhydramine (or similar antihistamine) as premedication.
Dexamethasone
Participants will receive dexamethasone as premedication.
Tocilizumab
Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration.
Tocilizumab biosimilar
Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration.
Siltuximab
Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration.