USO 23287
A Phase III, randomized, multi-site, open-label trial of BNT323/DB-1303 versus investigators choice of chemotherapy in previously treated patients with HER2-expressing recurrent endometrial cancer (BNT323-01)
Disease Types: GYN Cancer Research
Eligibility Requirements:
• Histologically confirmed endometrial cancer (EC)
• Uterine carcinosarcoma is allowed, but true sarcomas excluded
• HER2 IHC 1+/2+ (Cohort 1) or 3+ (Cohort 2) by central testing
• Measurable disease per RECIST 1.1
• Have recurrent EC and:
• Recurrence <12 months after plt-based chemo as adj tx for Stage I-III OR
• Recurrence after plt-based chemo in recurrent/metastatic setting
• Have received prior ICI tx (anti-PD-(L)1)
• Up to 3 lines of prior tx.
• Prior hormonal or radiation tx do not count as prior lines of tx
• Neoadjuvant followed by adjuvant tx is considered 1 line of tx
• Discontinuation due to toxicity followed by start of new anti-cancer tx
counts as 1 line of tx
• Prior tx with TOP1i, including ADCs, are excluded
For more information on this trial CLICK HERE .
Available at: