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

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.

Eligibility

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

Conditions3

Locations60 sites

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