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

Launched by ASTRAZENECA · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called puxitatug samrotecan to see how well it works and how safe it is compared to standard chemotherapy in women with advanced or spreading endometrial cancer, a type of cancer that starts in the lining of the uterus. The study focuses on patients whose cancer has certain characteristics (called B7-H4 positive) and who have already tried common treatments like platinum-based chemotherapy and immunotherapy but whose cancer has continued to grow or come back.

Women who might be eligible for this trial are those diagnosed with endometrial cancer or a related type called carcinosarcoma, whose cancer has returned or spread, and who are generally in good health with measurable tumors on scans. Participants will be randomly assigned to receive either the new drug or one of the usual chemotherapy medicines chosen by their doctor. The trial is not yet recruiting patients, and it excludes women who have had certain other types of uterine cancers, previous treatments with similar drugs, or serious lung or autoimmune conditions. This study aims to find better treatment options for women with advanced endometrial cancer that has not responded to previous therapies.

Gender

FEMALE

Eligibility criteria

• 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 AZD8205 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