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

Recruiting now Phase 3 NCT07044336

Run by AstraZeneca · for 18 and older · Women

What this study is about

This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based chemotherapy and anti-PD-1/anti-PD-L1 therapy.

Who can join (things the study team will check)

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 t…

Where this trial is running

Research Site, Tucson, Arizona, United States
Research Site, La Jolla, California, United States
Research Site, Los Angeles, California, United States
Research Site, Orange, California, United States
Research Site, Washington D.C., District of Columbia, United States
Research Site, Jupiter, Florida, United States
Research Site, Miami, Florida, United States
Research Site, Miami, Florida, United States
Research Site, Miami Beach, Florida, United States
Research Site, New Port Richey, Florida, United States
Research Site, Orlando, Florida, United States
Research Site, Tampa, Florida, United States

+ 305 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07044336.

Open the interactive checklist for this trial →

Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.

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