Home › Trials › NCT07044336

Puxitatug samrotecan versus chemotherapy for B7-H4–positive advanced endometrial cancer

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)

Phase 3 Interventional AstraZeneca · NCT07044336

This trial will test whether puxitatug samrotecan helps people with B7‑H4–positive advanced or metastatic endometrial cancer live longer or keep their cancer from getting worse compared with standard chemotherapy after platinum and PD‑1/PD‑L1 treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years and up
SexFemale
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, doxorubicin
Locations307 sites (Tucson, Arizona and 306 other locations)
Trial IDNCT07044336 on ClinicalTrials.gov

What this trial studies

This phase III, open-label, randomized 1:1 study enrolls approximately 700 participants with B7‑H4–selected advanced or metastatic endometrial carcinoma or carcinosarcoma who progressed after platinum-based chemotherapy and anti‑PD‑1/PD‑L1 therapy. Participants receive either IV puxitatug samrotecan every 3 weeks or physician's choice of IV doxorubicin every 3 weeks or IV paclitaxel on Days 1, 8, and 15 of a 28‑day cycle. The primary aims are to determine whether puxitatug samrotecan prolongs progression-free survival or overall survival compared with standard chemotherapy, with additional evaluation of safety and patient-reported quality of life. Eligible participants must have measurable disease by RECIST 1.1, ECOG 0–1, and no more than two prior lines of therapy in the advanced/metastatic setting.

Who should consider this trial

Good fit: Ideal candidates are people with B7‑H4–selected advanced or metastatic endometrial carcinoma or carcinosarcoma who progressed after platinum-based and anti‑PD‑1/PD‑L1 therapy, have measurable disease, ECOG 0–1, and have received no more than two prior lines for advanced disease.

Not a fit: Patients with uterine sarcomas or neuroendocrine carcinomas, those with recurrence more than 12 months after curative-intent platinum without additional platinum in the recurrent setting, those who received more than two prior advanced therapies, or those with poor performance status are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, puxitatug samrotecan could extend progression-free and overall survival and provide a new targeted option for B7‑H4–positive patients who have limited choices after platinum and PD‑1/PD‑L1 therapy.

How similar studies have performed: B7‑H4–directed antibody–drug conjugates are a relatively new approach; early-phase data suggest potential activity but there is not yet definitive phase‑III evidence supporting this mechanism in endometrial cancer.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Tucson, Arizona and 306 other locations

+257 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Endometrial CancerMalignant Solid TumourBluestar-Endometrial01AZD8205Puxitatug SamrotecanPuxi-SamPlatinum-based chemotherapyB7-H4
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.