Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4 Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)
AstraZeneca
700 participants
Aug 1, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria7
- 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
Interventions
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
60 mg/m2 on Day 1 Q3W Route of administration: IV
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Locations(294)
View Full Details on ClinicalTrials.gov
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NCT07044336