Study on Investigational Therapy or Chemotherapy for Recurring Uterine Cancer
Sponsor: BioNTech SE
ClinicalTrials ID:NCT06340568
This clinical trial is exploring the effects of a new investigational therapy, BNT323, compared to standard chemotherapy in women with recurring uterine cancer. The study aims to determine how well these treatments work and their safety.
Patient Parameters
| Parameter | Options |
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Program Overview
The study is divided into two groups based on the level of a protein called HER2 in the tumor. In the first group, researchers will compare the effectiveness of BNT323 or standard chemotherapy (doxorubicin or paclitaxel) in patients who have already been treated with immune checkpoint inhibitors. The second group will focus on how well BNT323 works on its own. The study will also monitor any side effects, how the drug moves through the body, the immune response, and the impact on quality of life.
Description
This clinical trial is testing a new treatment called BNT323 against standard chemotherapy in women with recurring uterine cancer. The study is open-label, meaning both the researchers and participants know which treatment is being given. Participants are divided into two groups based on the HER2 protein level in their cancer. In the first group, participants will receive either BNT323 or a chemotherapy drug chosen by their doctor. In the second group, participants will receive only BNT323. The study will track how long participants live without their cancer getting worse, how many participants see their tumors shrink or disappear, and any side effects. The study includes a screening period, treatment period, and follow-up periods to monitor safety and effectiveness over time. Participants can expect to be in the study for about six months of treatment, with follow-up lasting up to 53 months.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 or older.
- Have confirmed uterine cancer that has come back.
- Cancer must have a specific HER2 protein level.
- Cancer must be measurable by scans.
- Have a good overall health status.
- Cancer must have returned after previous chemotherapy or within 12 months of completing it.
- Have been treated with immune checkpoint inhibitors before.
- Have a life expectancy of at least 12 weeks.
Exclusion Criteria
- Cannot receive any of the chemotherapy options available in the study.
- Have had a bowel obstruction requiring hospitalization in the last 3 months.
- Have uncontrolled health issues that could interfere with the study.
- Have fluid buildup around the lungs, heart, or abdomen that needs draining.
- Have lung disease or inflammation that required steroids.
- Have used immunosuppressive medication recently, except for certain low-dose steroids.
- Have serious lung conditions or autoimmune diseases affecting the lungs.
- Have an active infection needing treatment.
- Have unresolved side effects from previous cancer treatments.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
- Have allergies to the study drugs or similar medications.
- Have had certain heart conditions or treatments affecting heart function.
- Have used topoisomerase I inhibitors before.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| MedStar Washington Hospital Center | 20010 | Washington D.C. | District of Columbia |
| Broward Health Medical Center | 33316 | Fort Lauderdale | Florida |
| The Center of Hope Reno | 89511 | Reno | Nevada |
| Laura & Isaac Perlmutter Cancer Center | 10016 | New York | New York |
| Miami Valley Hospital South | 45459 | Centerville | Ohio |
| Ohio State University | 43026 | Hilliard | Ohio |
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