Treatment
Participants will be randomized 2:1 to receive either BNT323/DB-1303 or investigator's choice of single agent chemotherapy (doxorubicin or paclitaxel).
Treatment duration
BNT323/DB-1303 is administered until disease progression, unacceptable toxicity or withdrawal of consent.
Eligibility
Main inclusion criteria:
- Have histologically confirmed endometrial cancer that:
- Is recurrent,
- Has a HER2 IHC score of 1+, 2+, or 3+ as determined by central laboratory testing for HER2 protein expression, and
- Is not defined as a true sarcoma (i.e., leiomyosarcoma or endometrial stromal sarcoma). Note: Uterine carcinosarcoma is allowed.
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-2
- Have had at least one prior line of platinum-based therapy (in any setting). Up to three lines of prior therapy are allowed. Prior hormonal therapy and radiation are allowed and do not count as prior lines of therapy.
Main exclusion criteria:
- Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to randomization.
- Have a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, have current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Had prior treatment with topoisomerase I inhibitors, including ADCs with exatecans.
Disclaimer: This is an overview of the main in- and exclusion criteria which can also be found on clinicaltrials.gov (NCT06340568). Criteria might change during the course of the study due to amendments. Inclusion in the trial remains the responsibility of the principal investigator of the trial and will depend on patient eligibility and slot availability.
Contact
In case you feel your patient might be eligible for this trial or in case you want to have more information about this trial, please feel free to contact us via: lgog@uzleuven.be