Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)

For females ages 18 years and up

The main inclusion criteria include but are not limited to the following:

• Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma.
• Recurrent/metastatic EC ie, with radiological or objective evidence of recurrence or progression.
• Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)/anti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.
• A WHO/ECOG performance status of 0 or 1 at Screening.
• Has radiographically measurable disease by RECIST 1.1

The main exclusion criteria include but are not limited to the following:

• Had uterine sarcomas or uterine neuroendocrine carcinoma.
• Has had a recurrence of endometrial carcinoma or carcinosarcoma more than > 12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting.
• Had previously received treatment with any therapy (approved or investigational) that contained a TOP1i including ADCs .
• Had previously received treatment with Puxi-Sam or another B7-H4 targeting agent.
• History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
• Active or previously documented autoimmune or inflammatory disorders