A Phase I First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.

Study Identifier:
HWK-016-101
CT.gov Identifier:
NCT07470853
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

To evaluate the effect of mMUC16-CPT113 For the treatment of ovarian cancer

To evaluating HWK-016, a targeted antibody-drug conjugate (ADC) in adult participants with advanced or metastatic solid tumors

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.
  • Ovarian
  • Endometrial
    • 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.
    I
    Sex
    Female
    Age
    18+ years
    Study Drug
  • Drug: Patients will receive mMUC16-CPT113
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Patient with ovarian cancer
    • Have one of the following solid tumor cancers:Monotherapy escalation, backfill and expansion cohorts:Endometrial CarcinomaOvarian CancerCombination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer
    Exclusion criteria
    • Individual with known or suspected uncontrolled central nervous system (CNS) metastasesIndividual with history of carcinomatous meningitisIndividual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infectionIndividual with evidence of corneal keratopathy or history of cornea transplantAny serious unresolved toxicities from prior therapySignificant cardiovascular diseaseProlongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)History of pneumonitis/interstitial lung diseaseIndividuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Los Angeles
    Los Angeles, CA, United States, 90025
    Investigator
    Lasika Seneviratne
    Status
    Recruiting
    Condition(s) Treated at Site
    Ovarian
    Endometrial
    Location
    START New York (Long Island)
    Lake Success, NY, United States, 11042
    Investigator
    Geraldine O'Sullivan Coyne
    Status
    Recruiting
    Condition(s) Treated at Site
    Ovarian
    Endometrial
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruiting
    Condition(s) Treated at Site
    Ovarian
    Endometrial