A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK-6255 Monotherapy in Advanced Solid Tumors

Study Identifier:
MK-6255-001
CT.gov Identifier:
NCT07870278
EudraCT Identifier:
202652576817
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Will Be Recruiting

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Study 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.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Dose Escalation
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Drug: Participants receive MK-6255 once every week (QW).
Drug: Drug: Acetaminophen
Drug: Participants will receive acetaminophen (or similar antipyretic) as premedication.
Drug: Drug: CD8 PET Tracer
Drug: Participants may receive an optional CD8 PET tracer for exploratory imaging assessments.
Drug: Other Names: GEH200520, GEH200521 (18F)
Drug: Drug: Dexamethasone
Drug: Participants will receive dexamethasone as premedication.
Drug: Drug: Diphenhydramine
Drug: Participants will receive diphenhydramine (or similar antihistamine) as premedication.
Drug: Drug: MK-6255
Drug: 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).
Drug: Drug: Siltuximab
Drug: Participants will receive this rescue medication at the investigator's discretion for treatment of cytokine release syndrome (CRS) after MK-6255 administration.
Drug: Drug: Tocilizumab biosimilar
Drug: Other Names: Avtozma®, Tyenne®
Drug: Drug: Tocilizumab
Drug: EXPERIMENTAL: Dose Interval Extension
Drug: Participants receive MK-6255 at extended interval dosing.
Study Status
Indicates the current recruitment status or the expanded access status
Will Be Recruiting

Requirements information
Inclusion criteria
  • 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
Exclusion criteria
  • The main exclusion criteria include but are not limited to the following:
  • * 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 a history of serious cardiovascular and cerebrovascular diseases
  • * Has a history or presence of clinically relevant central nervous system (CNS) diseases
  • * 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 known additional malignancy that is progressing or has required active treatment within the past 3 years
  • * Has known active CNS metastases and/or carcinomatous meningitis
  • * 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
  • * Has not adequately recovered from major surgery or has ongoing surgical complications

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START New Jersey
East Brunswick, NJ, United States, 08816
Investigator
Status
Will Be Recruiting
Condition(s) Treated at Site