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

RecruitingPhase 3Ages 18 Years - anyFemaleAstraZeneca
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Puxitatug Samrotecan
  • Doxorubicin
  • Paclitaxel
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Where

320 sites
Research Site
Tucson, United States
Research Site
La Jolla, United States
Research Site
Los Angeles, United States
Research Site
Orange, United States
Research Site
Washington D.C., United States
Research Site
Jupiter, United States
Research Site
Miami, United States
Research Site
Miami, United States

โ€ฆand 312 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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