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

NCT 07044336

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.

Intervention / Treatment 

  • Drug: Puxitatug Samrotecan
  • Drug: Doxorubicin
  • Drug: Paclitaxel

Inclusion 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.

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