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    Cancer Clinical Trials

    A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer (Fern-EC-01)

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    What is the purpose of this study?

    The study is divided into two cohorts (Cohort 1 and Cohort 2), to which participants will be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample. In Cohort 1, the main goal is to assess how well BNT323 (also known as DB-1303) or chemotherapy (doxorubicin or paclitaxel \[or docetaxel, if participants cannot take paclitaxel\]) works by determining the progression-free survival (PFS) of participants who have been previously treated with immune checkpoint inhibitors (ICIs). In Cohort 2, the main goal is to assess how well BNT323 works by determining the objective response rate (ORR), that is, the percentage of participants whose tumor shrinks (partial response) or disappears (complete response) after treatment. The safety of BNT323 will also be assessed by following the occurrence of unfavorable/adverse effects that are seen after treatment. Other measures include the pharmacokinetics of BNT323 (or how BNT323 moves through and out of the body), the body's immune response, and the impact on quality of life.

    Eligibility

    Key Inclusion Criteria:

    • Are female adults (defined as ≥18 years of age or acceptable age according to local regulations at the time of voluntarily giving informed consent).

    • Have histologically confirmed endometrial cancer that:

      • Is recurrent,
      • Has a HER2 IHC score of 1+, 2+ (Cohort 1), or 3+ (Cohort 2) as determined by central laboratory testing for HER2 expression, and
      • Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma is allowed.
    • Have measurable disease defined by RECIST v1.1.

    • Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.

    • Have recurrent endometrial cancer and meet any of the following:

      • developed recurrence <12 months from completing platinum-based chemotherapy given as adjuvant therapy for Stage I to III disease, or
      • developed recurrence after platinum-based chemotherapy in the recurrent/metastatic setting.
    • Have received prior ICI treatment (i.e., anti-programmed death 1/anti-programmed death-ligand 1)

    • Have a life expectancy of ≥12 weeks at screening.

    Where can I participate?

    Hoag Hospital Newport Beach
    1 Hoag Dr
    Newport Beach, CA 92663


    Lauren Wagner

    lauren.wagner@hoag.org


    Hoag Hospital Irvine
    16200 Sand Canyon Ave
    Irvine, CA 92618


    Lauren Wagner

    lauren.wagner@hoag.org


    More about this Clinical Trial

    What is the full name of this Clinical Trial?

    A Phase III, Randomized, Multi-site, Open-label Trial of BNT323/DB-1303 Versus Investigator's Choice of Chemotherapy in Previously Treated Patients With HER2- Expressing Recurrent Endometrial Cancer

    • Disease Type/ConditionEndometrial Cancer
    • Principal InvestigatorMonica Mita. MD
    • Co-InvestigatorsChaitali S. Nangia, MD, Laura Beals, NP, Sharmeen Mahmood, DO, Yaser Homsi, MD, Alain Mita, MD
    • Age GroupAdult, Older Adult
    • PhaseIII
    • ClinicalTrials.gov IDNCT06340568

    Hoag Family Cancer Institute

    Hoag Family Cancer Institute delivers advanced, compassionate cancer care across Orange County, with multidisciplinary specialists, precision therapies, support services, and access to 125+ cancer clinical trials. Patients benefit from research-driven care across a wide range of cancers, including breast, lung, gynecologic, prostate, gastrointestinal, and blood cancers.

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