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Clinical Trials List

Protocol NumberBNT323-01
NCT Number(ClinicalTrials.gov Identfier)NCT06340568
Active

2025-03-01 - 2030-03-31

Phase III

Recruiting6

ICD-10C54.1

Malignant neoplasm of endometrium

ICD-10C54.2

Malignant neoplasm of myometrium

ICD-10C54.3

Malignant neoplasm of fundus uteri

ICD-10C54.9

Malignant neoplasm of corpus uteri, unspecified

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9182.0

Malignant neoplasm of corpus uteri, except isthmus

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

  • Trial Applicant

    IQVIA RDS Taiwan Ltd.

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/10

Investigators and Locations

Principal Investigator Chien-Hsing Lu Division of Obstetrics & Gynecology
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭集慶 Division of Hematology & Oncology
Kuang Tien General Hospital

Co-Principal Investigator

  • 魏志尚 Division of Obstetrics & Gynecology
  • 魏志尚 Division of Obstetrics & Gynecology

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張志隆 Division of Obstetrics & Gynecology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Peng-Hui Wang Division of Obstetrics & Gynecology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Fang Huang
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Endometrial Cancer

Objectives

The primary objective of this trial was to evaluate the efficacy of BNT323 versus chemotherapy selected by the trial administrator in terms of progression-free survival (PFS) in a population of endometrial cancer patients who had previously received immune checkpoint inhibitor (ICI) therapy, through a blinded independent central review (BICR).

Test Drug

Solution Powder

Active Ingredient

BNT323

Dosage Form

145

Dosage

100 mg/5 mL

Endpoints

BICR-assessed progression-free survival (PFS) is defined as the time elapsed from randomization to the occurrence of the first objective tumor progression (according to RECIST version 1.1) or death from any cause, whichever comes first.

Inclution Criteria

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.

Exclusion Criteria

Key Exclusion Criteria:

Are ineligible for all options in the investigator's choice of chemotherapy arm, per local prescribing information and institutional guidelines (applicable to Cohort 1 only).
Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior the first dose of study treatment.
Have an uncontrolled intercurrent illness that would limit compliance with study requirement or substantially increase risk of incurring adverse events.
Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, or peritoneal shunt within 2 weeks prior to the first dose of study treatment.
Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Participants with prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses of less than 10 mg/day of prednisone or equivalent, and topical corticosteroids. Participants receiving corticosteroids may continue if the dose is stable upon giving main informed consent.
Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary emboli within 3 months prior to the first dose of study treatment, severe asthma, chronic obstructive pulmonary disorder with moderate acute exacerbations, restrictive lung disease, pulmonary fibrosis, radiation pneumonitis, significant pleural effusion etc.), or any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis etc.), and/or prior pneumonectomy (complete).
Have uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose of study treatment.
Have unresolved toxicities from previous anti-cancer therapy, defined as toxicities (other than alopecia, fatigue, or endocrinopathies that are well controlled) not yet resolved to Grade ≤1 or baseline.
Are pregnant or breastfeeding or are planning pregnancy during the study or within 7 months after the last dose of study treatment.
Have a history of allergies, hypersensitivities, or intolerance to study treatments (investigational medicinal products and auxiliary medicinal product) including any excipients thereof or to other monoclonal antibodies. Participants who have successfully undergone a desensitization process and are able to tolerate the drug are eligible.
Had prior treatment with topoisomerase I inhibitors, including ADCs.
Have left ventricular ejection fraction <55% by either echocardiography or multiple-gated acquisition within 28 days prior to the first dose of study treatment. This includes participants with tissue doppler E/e' ratio >15.
NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

The Estimated Number of Participants

  • Taiwan

    15 participants

  • Global

    504 participants

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