BridgeMD
A clinical study of the anti-cancer effects of an investigational therapy or chemotherapy in patients with recurring uterine cancer
EU CTIS ID: 2023-507525-42-00
What this study is testing
Cohort 1, participants with HER2 IHC 1+/2+ recurrent endometrial cancer: To assess the efficacy of BNT323 compared to investigator’s choice of chemotherapy in terms of a hazard ratio (HR) for progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 assessed by blinded independent central review (BICR) in participants with human epidermal growth factor receptor 2 (HER2) IHC 1+/2+ recurrent endometrial cancer. Cohort 2, participants with HER2 IHC 3+ recurrent endometrial cancer: To assess the efficacy of BNT323 in terms of objective response rate (ORR) according to RECIST 1.1 assessed by blinded independent central review (BICR) in participants with HER2 IHC 3+ recurrent endometrial cancer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Are female adults.
- 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.
- Have measurable disease defined by RECIST 1.1.
- 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 within less than 12 months from completing platinum-based chemotherapy as adjuvant therapy for Stage I to III disease, or -developed recurrence after platinum-based chemotherapy in the recurrent / metastatic setting.
- Have a life expectancy of 12 weeks or longer at screening.
You likely can't join if
- Are ineligible for all options in the investigator’s choice chemotherapy arm, per local prescribing information and institutional guidelines (applicable to Cohort 1 only).
- 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 trial treatments 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 antibody-drug conjugates (ADCs).
- Have left ventricular ejection fraction (LVEF) below 55% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days prior to the first dose of trial treatment.
- Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of trial treatment.
See the full eligibility criteria
- Are female adults.
- 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.
- Have measurable disease defined by RECIST 1.1.
- 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 within less than 12 months from completing platinum-based chemotherapy as adjuvant therapy for Stage I to III disease, or -developed recurrence after platinum-based chemotherapy in the recurrent / metastatic setting.
- Have a life expectancy of 12 weeks or longer at screening.
- Have received prior immune-checkpoint inhibitor (ICI) treatment (i.e., anti-PD-1/anti-PD-L1).
- Up to three lines of prior therapy are allowed.
- Are ineligible for all options in the investigator’s choice chemotherapy arm, per local prescribing information and institutional guidelines (applicable to Cohort 1 only).
- 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 trial treatments 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 antibody-drug conjugates (ADCs).
- Have left ventricular ejection fraction (LVEF) below 55% by either echocardiography (ECHO) or multiple-gated acquisition (MUGA) within 28 days prior to the first dose of trial treatment.
- Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of trial 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 trial 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 trial treatment, except for intranasal and inhaled corticosteroids or systemic corticosteroids at doses of less than 10 mg/day of prednisone or equivalent. 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, or any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement, and/or prior pneumonectomy (complete).
- Have uncontrolled infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks prior to the first dose of trial 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 below, or baseline.
The study team makes the final eligibility decision.
Where it's taking place
- India
- United States
- Argentina
- Taiwan
- Brazil
- United Kingdom
- Turkey
- Israel
- China
- Canada
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India; United States; Argentina; Taiwan; Brazil; United Kingdom and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.