OncoMatch/Clinical Trials/NCT07044336
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
Is NCT07044336 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Chemotherapy
Other
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
Demographics
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 →Frequently asked questions
Is NCT07044336 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior topoisomerase I inhibitor, B7-H4 targeting agent disqualifies patients from enrollment.
Does this trial require VTCN1?
Yes, VTCN1 overexpression is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages