Recruiting
Phase 3

Puxitatug Samrotecan vs. Chemotherapy

Sponsor:

AstraZeneca

Code:

NCT07044336

Conditions

Endometrial Cancer

Malignant Solid Tumour

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Puxitatug Samrotecan

Doxorubicin

Paclitaxel

Study Details

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.

Conditions

Endometrial Cancer

Malignant Solid Tumour

Study ID

NCT07044336

Start date

Aug 1, 2025

Status verified date

Jul, 2026

Completion date

Jul 17, 2029

Anticipated

Primary completion date

Oct 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Puxitatug Samrotecan

Puxi-Sam IV (intravenous) Q3W .

active comparator: Chemotherapy

Physician's choice of chemotherapy

Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles.

Interventions

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

Primary outcome measure

  • Progression Free Survival (PFS) for Arm A vs Arm B [ Time Frame: Approximately 3 years ]
  • Overall survival (OS) for Arm A vs Arm B [ Time Frame: Approximately 3 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

La Jolla, California, United States, 92037

Research Site

Recruiting

Orange, California, United States, 92868

Research Site

Recruiting

Jupiter, Florida, United States, 33458

Research Site

Recruiting

Miami, Florida, United States, 33176

Research Site

Recruiting

Miami Beach, Florida, United States, 33140

Research Site

Recruiting

New Port Richey, Florida, United States, 34655

Research Site

Recruiting

Orlando, Florida, United States, 32806

Research Site

Recruiting

West Palm Beach, Florida, United States, 33401

Research Site

Recruiting

Chicago, Illinois, United States, 60607

Research Site

Recruiting

Peoria, Illinois, United States, 61637

Research Site

Recruiting

Urbana, Illinois, United States, 61801

Research Site

Recruiting

Fort Wayne, Indiana, United States, 46845

Research Site

Recruiting

Indianapolis, Indiana, United States, 46260

Research Site

Recruiting

Scarborough, Maine, United States, 04074

Research Site

Recruiting

Baltimore, Maryland, United States, 21231

Research Site

Recruiting

Silver Spring, Maryland, United States, 20910

Research Site

Recruiting

Ann Arbor, Michigan, United States, 48197

Research Site

Recruiting

Minneapolis, Minnesota, United States, 55404

Research Site

Recruiting

Paramus, New Jersey, United States, 07652

Research Site

Recruiting

Albuquerque, New Mexico, United States, 87109

Research Site

Recruiting

Stony Brook, New York, United States, 11794

Research Site

Recruiting

The Bronx, New York, United States, 10461

Research Site

Recruiting

White Plains, New York, United States, 10601

Research Site

Recruiting

Greenville, North Carolina, United States, 27834

Research Site

Recruiting

Pinehurst, North Carolina, United States, 28374

Research Site

Recruiting

Cincinnati, Ohio, United States, 45220

Research Site

Recruiting

Cleveland, Ohio, United States, 44106

Research Site

Recruiting

Cleveland, Ohio, United States, 44109

Research Site

Recruiting

Columbus, Ohio, United States, 43219

Research Site

Recruiting

Dayton, Ohio, United States, 45459

Research Site

Recruiting

Hilliard, Ohio, United States, 43026

Research Site

Recruiting

Sylvania, Ohio, United States, 43560

Research Site

Recruiting

Eugene, Oregon, United States, 97401

Research Site

Recruiting

Bethlehem, Pennsylvania, United States, 18015

Research Site

Recruiting

Hershey, Pennsylvania, United States, 17033

Research Site

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Research Site

Recruiting

Sioux Falls, South Dakota, United States, 57105

Research Site

Recruiting

Knoxville, Tennessee, United States, 37920

Research Site

Recruiting

Austin, Texas, United States, 78758

Research Site

Recruiting

Tyler, Texas, United States, 75702

Research Site

Recruiting

Fairfax, Virginia, United States, 22031

Research Site

Recruiting

Falls Church, Virginia, United States, 22042

Research Site

Recruiting

Norfolk, Virginia, United States, 23502

Research Site

Recruiting

Richmond, Virginia, United States, 23298

Research Site

Recruiting

Roanoke, Virginia, United States, 24016

Research Site

Recruiting

Morgantown, West Virginia, United States, 26505

Research Site

Recruiting

Waukesha, Wisconsin, United States, 53188

More Information

Sponsor

AstraZeneca

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Bluestar-Endometrial01
  • AZD8205
  • Puxitatug Samrotecan
  • Puxi-Sam
  • Platinum-based chemotherapy
  • B7-H4
  • advanced/metastatic
  • Endometrial Cancer
  • Anti-PD-1
  • Anti-PD-L1
  • antibody-drug conjugate
  • Topoisomerase 1 Inhibitors
  • uterine neoplasm
  • female urogenital neoplasm

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-07-29.