A Phase I, multicenter, open-label study in adult participants that will employ a sequential dose-escalation and expansion design to evaluate the safety, pharmacokinetics and preliminary antitumor activity of HWK-007 in participants with advanced or metastatic solid tumors that are refractory to standard therapies.

Study Identifier:
HWK-007-101
CT.gov Identifier:
NCT07444814
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 safety, pharmacokinetics and preliminary antitumor activity of HWK-007 in participants with advanced or metastatic solid tumors that are refractory to standard therapies.

HWK-007-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-007, a protein tyrosine kinase 7 (PTK7)-targeted antibody drug conjugate (ADC), in adult participants with advanced or metastatic solid tumors known to be expressing PTK7. The study employs a sequential dose escalation and dose expansion design without a control group.

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.
  • Endometrial
  • Ovarian
  • Non-Small Cell Lung Cancer
    • 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 & Male
    Age
    18+ years
    Study Drug
  • Drug: patient will receive PTK7-CPT113
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Inclusion Criteria:
    • Have one of the following solid tumor cancers:
    • Monotherapy escalation and backfill cohorts:non-squamous EGFR-Wt NSCLCEndometrial carcinomaPlatinum Resistant Ovarian CancerMonotherapy expansion cohorts:Non-squamous EGFR-Wt NSCLCAdditional tumor indications to be defined in a future amendment
    Exclusion criteria
    • 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 San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Drew Rasco
    Status
    Recruiting
    Condition(s) Treated at Site
    Endometrial
    Ovarian
    Non-Small Cell Lung Cancer
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Endometrial
    Ovarian
    Non-Small Cell Lung Cancer