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

Study acronym: Fern-EC-01
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints: details revised at 1 of 2 entries Trial sites expanded: 181 → 191 locations · Interventions: BNT323/DB-1303 (Drug), Docetaxel (Drug), Doxorubicin (Drug), Paclitaxel (Drug) to BNT323/DB-1303 (Drug), Docetaxel (Drug), Doxorubicin (Drug), Paclitaxel (Drug) · Secondary endpoints: details revised at 9 of 16 entries · 3 more Show 6 more changesShow less
    • Trial sites expanded: 181 → 191 locations
    • Interventions: BNT323/DB-1303 (Drug), Docetaxel (Drug), Doxorubicin (Drug), Paclitaxel (Drug) to BNT323/DB-1303 (Drug), Docetaxel (Drug), Doxorubicin (Drug), Paclitaxel (Drug)
    • Secondary endpoints: details revised at 9 of 16 entries
    • Study description revised
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria shortened, about 1 word
  2. Trial sites expanded: 171 → 181 locationsv18
  3. Trial sites expanded: 163 → 171 locationsv17
  4. Trial sites expanded: 156 → 163 locationsv16
  5. Trial sites expanded: 132 → 156 locationsv15
  6. Trial sites expanded: 112 → 132 locationsv14
  7. Trial sites expanded: 80 → 112 locationsv13
  8. Primary endpoints: 1 to 2 Enrollment target: 504 to 480 · Study sites: 52 to 80 · Interventions: BNT323/DB-1303 (Drug), Doxorubicin (Drug), Paclitaxel (Drug) to BNT323/DB-1303 (Drug), Docetaxel (Drug), Doxorubicin (Drug), Paclitaxel (Drug) · 5 morev12 Show 8 more changesShow less
    • Enrollment target: 504 to 480
    • Study sites: 52 to 80
    • Interventions: BNT323/DB-1303 (Drug), Doxorubicin (Drug), Paclitaxel (Drug) to BNT323/DB-1303 (Drug), Docetaxel (Drug), Doxorubicin (Drug), Paclitaxel (Drug)
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: 9 to 16
    • Study description expanded, about 54 words
    • Collaborators: 1 to 2
    • Study arms: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

  9. Study sites: 26 to 52v11
  10. Study sites: 21 to 26v10
  11. Study sites: 8 to 21v9
  12. Study sites: 1 to 8v8
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Completion date: Jan 2030 to Nov 2029 · Start date changed from estimate of Jun 2025 to Jun 10, 2025v7 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Completion date: Jan 2030 to Nov 2029
    • Start date changed from estimate of Jun 2025 to Jun 10, 2025
  14. Primary endpoint revised Enrollment target: 468 to 504 · Primary completion date: Oct 2027 to Mar 2028 · Completion date: Aug 2029 to Jan 2030 · 3 morev6 Show 6 more changesShow less
    • Enrollment target: 468 to 504
    • Primary completion date: Oct 2027 to Mar 2028
    • Completion date: Aug 2029 to Jan 2030
    • Eligibility criteria shortened, about 112 words
    • Secondary endpoints: 6 to 9
    • Study description expanded, about 39 words

    See this version in full on ClinicalTrials.gov ↗

  15. Start date: Jan 2025 to Jun 2025 Primary completion date: May 2027 to Oct 2027 · Completion date: Mar 2029 to Aug 2029v5 Show 2 more changesShow less
    • Primary completion date: May 2027 to Oct 2027
    • Completion date: Mar 2029 to Aug 2029
  16. Start date: Nov 2024 to Jan 2025v4
  17. Start date: Aug 2024 to Nov 2024 Primary completion date: Feb 2027 to May 2027 · Completion date: Dec 2028 to Mar 2029v3 Show 2 more changesShow less
    • Primary completion date: Feb 2027 to May 2027
    • Completion date: Dec 2028 to Mar 2029
  18. Start date: Apr 2024 to Aug 2024 Primary completion date: Oct 2026 to Feb 2027 · Completion date: Aug 2028 to Dec 2028v2 Show 2 more changesShow less
    • Primary completion date: Oct 2026 to Feb 2027
    • Completion date: Aug 2028 to Dec 2028
  19. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06340568
Lead Sponsor BioNTech SE
Collaborators: DualityBio Inc., BioNTech (Shanghai) Pharmaceuticals Co., Ltd.
Conditions Endometrial Cancer
Enrollment 480 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov