Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-28 @ 9:48 AM
Study NCT ID:
NCT06340568
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of the Anti-cancer Effects of an Investigational Therapy or Chemotherapy in Patients With Recurring Uterine Cancer
Sponsor:
BioNTech SE
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Fern-EC-01
Brief Summary:
The goal of this clinical study is to assess the efficacy of BNT323/DB-1303 compared with investigator's choice of chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the endometrial cancer population with prior immune checkpoint inhibitor (ICI) treatment.
Detailed Description:
This is an open-label, randomized, multi-site, Phase III, interventional clinical study designed to determine the efficacy and safety of BNT323/DB-1303 compared with investigator's choice of single agent chemotherapy in previously treated participants with recurrent endometrial cancer, whose disease has progressed on at least one line of platinum-based therapy.
Participants will be randomized 2:1 to receive either BNT323/DB-1303 or investigator's choice of single agent chemotherapy (doxorubicin or paclitaxel) until Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) defined progressive disease (PD) unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met. Randomization will be stratified by HER2 expression (immunohistochemistry score 1+ vs 2+ vs 3+), number of prior lines of therapy (1 vs 2+), and prior ICI treatment (yes vs no).
The study consists of a two-part screening period (Part 1 \[tissue screening\] and Part 2 \[screening\]) a treatment period, a safety follow-up period, an efficacy follow-up period, and a long-term survival follow-up. The expected treatment duration per participant is \~6 months, followed by an anticipated long-term survival follow-up period of up to 55 months.
Participants will be randomized 2:1 to receive either BNT323/DB-1303 or investigator's choice of single agent chemotherapy (doxorubicin or paclitaxel) until Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) defined progressive disease (PD) unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met. Randomization will be stratified by HER2 expression (immunohistochemistry score 1+ vs 2+ vs 3+), number of prior lines of therapy (1 vs 2+), and prior ICI treatment (yes vs no).
The study consists of a two-part screening period (Part 1 \[tissue screening\] and Part 2 \[screening\]) a treatment period, a safety follow-up period, an efficacy follow-up period, and a long-term survival follow-up. The expected treatment duration per participant is \~6 months, followed by an anticipated long-term survival follow-up period of up to 55 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: