NCT07870278Not yet recruitingPhase 1
A Clinical Trial of MK-6255 to Treat Endometrial and Ovarian Cancer (MK-6255-001)
A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK-6255 Monotherapy in Advanced Solid Tumors
Source: ClinicalTrials.gov · Last updated 13 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 6 Oct 2026
- Start date
- 13 Nov 2026
- Primary completion date
- 5 Jul 2031
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Ovarian cancer
- NCT number
- NCT07870278
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 80
- From 13 Nov 2026 to the primary completion date, 5 Jul 2031
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Has a diagnosis of any 1 of the following: Primary platinum-refractory OC; neuroendocrine tumors or endometrial sarcoma, including stromal sarcoma, leiomyosarcoma, adenosarcoma, or other types of pure sarcomas; carcinosarcoma; EC that is amenable to curative-intent surgery or curative-intent radiotherapy; or EC that requires recurrent drainage of effusions
- Has received prior systemic anticancer therapy within 4 weeks or 5 half-lives (whichever is shorter) before start of study intervention
- Has received prior radiotherapy within 2 weeks of start of study intervention
- Has not adequately recovered from major surgery or has ongoing surgical complications
Other illness
- Has a history of serious cardiovascular and cerebrovascular diseases
- Has a history or presence of clinically relevant central nervous system (CNS) diseases
- Has known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has active autoimmune disease that has required systemic treatment in the past 2 years
- Is living with HIV and has a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
- Has a history of stem cell/solid organ transplant
Other
- The main exclusion criteria include but are not limited to the following:
- Has known active CNS metastases and/or carcinomatous meningitis
Who the study is looking for
- The main inclusion criteria include but are not limited to the following:
- Has one of the following diagnoses:
- Recurrent, pathologically documented epithelial OC, primary peritoneal cancer, or fallopian tube cancer that is either (1) platinum resistant or (2) platinum sensitive, with progression during prior treatment with poly-adenosine diphosphate (ADP) ribose polymerase inhibitor (PARPi)
- Histologically confirmed well, moderately, or poorly differentiated (ie, Grade 1 to Grade 3) serous or endometrioid EC that has progressed after at least 1 line of platinum-based therapy in any setting
- Has received all protocol-required and available standard of care (SOC) therapies, unless ineligible for or intolerant to the therapies
- Has provided archival tumor tissue or a recently obtained biopsy before treatment start
- If living with human immunodeficiency virus (HIV), has well-controlled HIV on antiretroviral therapy (ART)
- If hepatitis B surface antigen (HBsAg)-positive, has undetectable hepatitis B virus (HBV) viral load and has received HBV antiviral - therapy for at least 4 weeks
- If history of hepatitis C virus (HCV) infection, has undetectable HCV viral load
- Has adequate organ function
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.