The study is divided into two cohorts (Cohort 1 and Cohort 2), to which you would 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).
Official registry: https://clinicaltrials.gov/study/NCT06340568 · BioNTech SE · enrollment listed as 480
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are BNT323/DB-1303, Doxorubicin, or Paclitaxel. The registry lists allocation as randomized. The study is divided into two cohorts (Cohort 1 and Cohort 2), to which you would be enrolled based on the amount of human epidermal growth factor receptor 2 (HER2) in their tumor sample.
They plan to enroll about 480 people at 214 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
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
Interventions: BNT323/DB-1303, Doxorubicin, Paclitaxel, Docetaxel
Primary outcome (registry wording): Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer
BioNTech clinical trials patient information
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 192 sites outside the US on the same record
We will investigate the clinical manifestations and molecular genetic defects of heritable urologic malignant disorders. Families with urologic malignancy with known or suspected genetic basis will be enrolled.
NCT00001238 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This protocol will evaluate patients with systemic lupus erythematosus (SLE) and their relatives to learn more about how the disease develops and changes over time. It will also study genetic factors that make a person susceptible to SLE.
NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
This study is designed to explore the genetics and pathophysiology of diseases presenting with intermittent fever, including familial Mediterranean fever, TRAPS, hyper-IgD syndrome, and related diseases. The following individuals may be eligible for this natural history study: 1) patients with known or suspected familial Mediterranean fever, TRAPS, hyper-IgD syndrome or related disorders; 2) relatives of these patients; 3) healthy, normal volunteers 7 years of age or older.
NCT00001373 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary