OncoMatch/Clinical Trials/NCT07044336
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
Is NCT07044336 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Puxitatug Samrotecan and Doxorubicin for endometrial cancer.
Treatment: Puxitatug Samrotecan · Doxorubicin · Paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: VTCN1 overexpression
B7-H4-selected Endometrial Cancer
Disease stage
Metastatic disease required
Performance status
WHO/ECOG 0–1
Prior therapy
Must have received: platinum-based chemotherapy
Has received prior platinum-based chemotherapy
Must have received: anti-PD-1 therapy
Has received prior ... anti-programmed cell death 1 protein (PD-1) ... therapy
Must have received: anti-PD-L1 therapy
Has received prior ... anti-programmed cell death ligand 1 (PD-L1) therapy
Cannot have received: topoisomerase I inhibitor
Had previously received treatment with any therapy (approved or investigational) that contained a TOP1i including ADCs
Cannot have received: B7-H4 targeting agent (Puxi-Sam)
Had previously received treatment with Puxi-Sam or another B7-H4 targeting agent
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Research Site · Honolulu, Hawaii
- Research Site · Chicago, Illinois
- Research Site · Peoria, Illinois
- Research Site · Urbana, Illinois
- Research Site · Fort Wayne, Indiana
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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