NCT07044336 Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
| NCT ID | NCT07044336 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | AstraZeneca |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-08-01 |
| Primary Completion | 2027-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 800 participants in total. It began in 2025-08-01 with a primary completion date of 2027-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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
Contact & Investigator
Brian Slomovitz, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT07044336 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07044336 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 800 participants.
Is NCT07044336 currently recruiting?
Yes, NCT07044336 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07044336 trial being conducted?
This trial is being conducted at Tucson, United States, La Jolla, United States, Los Angeles, United States, Orange, United States and 11 additional locations.
Who is sponsoring the NCT07044336 clinical trial?
NCT07044336 is sponsored by AstraZeneca. The principal investigator is Brian Slomovitz, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 800 participants.
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