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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
BioNTech SE
Study ID
NCT06340568
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BNT323/DB-1303 — DRUG
    intravenous (IV) infusion
  • Doxorubicin — DRUG
    IV bolus or infusion
  • Paclitaxel — DRUG
    IV infusion
  • Docetaxel — DRUG
    IV infusion

Study Details

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.

Key Dates

Start date
Jun 10, 2025
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (HER2 IHC score 1+ or 2+): BNT323/DB-1303
  • Active Comparator: Cohort 1 - Doxorubicin or paclitaxel (or docetaxel)
    Single agent chemotherapy (either doxorubicin or paclitaxel) per investigator's choice. Participants with contraindications to paclitaxel may receive docetaxel as an alternative (if available at the site).
  • Experimental: Cohort 2 (HER2 IHC score 3+) - BNT323/DB-1303

Primary Outcome Measure

Cohort 1: PFS assessed by blinded independent central review (BICR) in participants with HER2 IHC 1+/2+ recurrent endometrial cancer [ Time Frame: Up to approximately 53 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
MedStar Washington Hospital CenterWashington D.C.District of Columbia20010-
Broward Health Medical CenterFort LauderdaleFlorida33316-
The Center of Hope RenoRenoNevada89511-
NYU Langone HealthNew YorkNew York10016-
Miami Valley Hospital SouthCentervilleOhio45459-
Ohio State UniversityHilliardOhio43026-
Sanford Cancer CenterSioux FallsSouth Dakota57104-

Find similar trials in Washington D.C., DC

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
MedStar Washington Hospital Center· Washington D.C., DCBroward Health Medical Center· Fort Lauderdale, FLThe Center of Hope Reno· Reno, NVNYU Langone Health· New York, NYMiami Valley Hospital South· Centerville, OHOhio State University· Hilliard, OH

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