Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
Condition(s) studied
Investigational drug(s) / intervention(s)
Puxitatug Samrotecan: 2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
Doxorubicin: 60 mg/m2 on Day 1 Q3W Route of administration: IV
Paclitaxel: 80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Study 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
Primary outcome measure(s)
- Progression Free Survival (PFS) for Arm A vs Arm B — Approximately 3 years
PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause. - Overall survival (OS) for Arm A vs Arm B — Approximately 3 years
OS is defined as the time from randomization until the date of death due to any cause.
Trial sites (320)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Tucson | Arizona | Not Yet Recruiting |
| Research Site | La Jolla | California | Recruiting |
| Research Site | Los Angeles | California | Withdrawn |
| Research Site | Orange | California | Recruiting |
| Research Site | Washington D.C. | District of Columbia | Not Yet Recruiting |
| Research Site | Jupiter | Florida | Recruiting |
| Research Site | Miami | Florida | Not Yet Recruiting |
| Research Site | Miami | Florida | Recruiting |
| Research Site | Miami Beach | Florida | Recruiting |
| Research Site | New Port Richey | Florida | Recruiting |
| Research Site | Orlando | Florida | Recruiting |
| Research Site | Tampa | Florida | Not Yet Recruiting |
| Research Site | West Palm Beach | Florida | Recruiting |
| Research Site | Honolulu | Hawaii | Not Yet Recruiting |
| Research Site | Chicago | Illinois | Recruiting |
| Research Site | Peoria | Illinois | Recruiting |
| Research Site | Urbana | Illinois | Recruiting |
| Research Site | Fort Wayne | Indiana | Recruiting |
| Research Site | Indianapolis | Indiana | Recruiting |
| Research Site | Scarborough | Maine | Recruiting |
| Research Site | Baltimore | Maryland | Not Yet Recruiting |
| Research Site | Baltimore | Maryland | Recruiting |
| Research Site | Silver Spring | Maryland | Recruiting |
| Research Site | Ann Arbor | Michigan | Not Yet Recruiting |
| Research Site | Ann Arbor | Michigan | Recruiting |
| Research Site | Detroit | Michigan | Withdrawn |
| Research Site | Minneapolis | Minnesota | Recruiting |
| Research Site | Camden | New Jersey | Not Yet Recruiting |
| Research Site | Paramus | New Jersey | Recruiting |
| Research Site | Albuquerque | New Mexico | Recruiting |
| Research Site | Brooklyn | New York | Not Yet Recruiting |
| Research Site | Stony Brook | New York | Recruiting |
| Research Site | The Bronx | New York | Recruiting |
| Research Site | White Plains | New York | Recruiting |
| Research Site | Greenville | North Carolina | Recruiting |
| Research Site | Pinehurst | North Carolina | Recruiting |
| Research Site | Cincinnati | Ohio | Recruiting |
| Research Site | Cleveland | Ohio | Recruiting |
| Research Site | Cleveland | Ohio | Recruiting |
| Research Site | Columbus | Ohio | Recruiting |
+ 280 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07044336 on ClinicalTrials.gov ↗ ← All trials in the UK