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Clinical Trials in the UK / NCT07044336
Recruiting Phase 3

Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)

NCT07044336 · tracked via the Priya Life Science UK tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-08-01
Last updated
2026-07-29

Condition(s) studied

Endometrial CancerMalignant Solid Tumour

Investigational drug(s) / intervention(s)

Puxitatug SamrotecanDoxorubicinPaclitaxel

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

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (320)

FacilityCityRegionStatus
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.

Official registry record

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