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

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.

Trial Details

NCT ID
NCT07044336
Phase
PHASE3
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Uterine Cancer
Interventions
  • Puxitatug Samrotecan
  • Doxorubicin
  • Paclitaxel
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • La Jolla, California, United States|32.84727,-117.2742
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311
  • Washington D.C., District of Columbia, United States|38.89511,-77.03637

Key Eligibility Criteria

  • 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…
  • A WHO/ECOG performance status of 0 or 1 at Screening.

For full eligibility, visit ClinicalTrials.gov.

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