Oncology Cardiology / Cardiovascular Respiratory / COPD / Asthma Infectious Disease Gastroenterology Neurology Diabetes / Metabolic Women's Health Rheumatology Mental Health / Psychiatry Dermatology Rare Diseases Men's Health
Clinical Trial ● Currently Recruiting Phase III NCT07044336

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

Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) — Recruiting • Phase III • Oncology • NCT07044336.

📅 20 May 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
Phase
Phase III
NCT ID
NCT07044336
Sponsor
AstraZeneca
Start
2025-08-01
ClinicaliQ Trial Snapshot
  • Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) — Recruiting • Phase III • Oncology • NCT07044336.
  • What is being tested: Puxitatug samrotecan (AZD8205), a B7-H4-targeted therapy, versus standard chemotherapy (doxorubicin or paclitaxel) in patients with advanced/metastatic endometrial cancer that has progressed after platinum-based treatment.
  • Patient eligibility overview: Adults with B7-H4-positive advanced or metastatic endometrial cancer whose disease has progressed following platinum-containing chemotherapy, representing a treatment-resistant population with limited therapeutic options.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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 Snapshot
  • 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

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
View Trial ↗
Share: Twitter/X LinkedIn
Related

Related Clinical Intelligence

Guidelines, Drug Science, safety briefs and education connected to this trial area.

Guideline
Durvalumab with platinum-based chemotherapy, then with or without olaparib, for untreated advanced or recurrent endometrial cancer
Oncology · 09 Sep 2026
Durvalumab combined with platinum-based chemotherapy is the recommended first-line treatment for untreated advanced or recurrent endometrial cancer, with olaparib addition considered based…
View guideline →
Guideline
Trastuzumab deruxtecan for treating HER2-low metastatic or unresectable breast cancer after chemotherapy
Oncology · 07 Oct 2026
Trastuzumab deruxtecan is recommended by NICE as a treatment option for HER2-low metastatic or unresectable breast cancer, making it suitable for patients…
View guideline →
Guideline
Dostarlimab for previously treated advanced or recurrent endometrial cancer with high microsatellite instability or mismatch repair deficiency
Oncology · 26 Aug 2026
Test for MSI-H/dMMR before treatment: All patients with advanced or recurrent endometrial cancer should undergo microsatellite instability or mismatch repair deficiency testing…
View guideline →
Guideline
Trastuzumab deruxtecan for treating HER2-positive unresectable or metastatic breast cancer after 1 or more lines of anti-HER2 treatment
Oncology · 20 Oct 2026
Trastuzumab deruxtecan is recommended as an option for HER2-positive unresectable or metastatic breast cancer only after 1 or more prior lines of…
View guideline →
Clinical Brief
Pope does not need further treatment after lung cancer surgery
Oncology · BBC Health · 21 Oct 2026
Localised lung adenocarcinoma identified post-operatively, indicating early-stage disease suitable for surgical intervention alone No adjuvant therapy deemed necessary following successful surgical resection…
View brief →
Clinical Brief
Emotional TV plea for cancer research leads to meeting with PM
Oncology · BBC Health · 15 Oct 2026
A Scottish athlete with inoperable brain tumours has successfully lobbied for increased investment in brain cancer research, highlighting the clinical need for…
View brief →