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NOT YET RECRUITING
NCT07870278
PHASE1

A Clinical Trial of MK-6255 to Treat Endometrial and Ovarian Cancer (MK-6255-001)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

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).

OTHER

CD8 PET Tracer

Participants may receive an optional CD8 PET tracer for exploratory imaging assessments.

DRUG

Acetaminophen

Participants will receive acetaminophen (or similar antipyretic) as premedication.

DRUG

Diphenhydramine

Participants will receive diphenhydramine (or similar antihistamine) as premedication.

DRUG

Dexamethasone

Participants will receive dexamethasone as premedication.

BIOLOGICAL

Tocilizumab

Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration.

BIOLOGICAL

Tocilizumab biosimilar

Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration.

BIOLOGICAL

Siltuximab

Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration.