Puxitatug Samrotecan vs Chemotherapy for Endometrial Cancer

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

Recruiting Phase 3 Interventional Study
Endometrial Cancer Malignant Solid Tumour
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
800 (estimated)
Sponsor
AstraZeneca · Industry
Who this trial is looking for

This trial is looking for women with a specific type of advanced endometrial cancer that has not responded to previous treatments. Participants will receive either a new drug called puxitatug samrotecan or standard chemotherapy chosen by their doctor.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with endometrial cancer or carcinosarcoma.
  • I have cancer that has come back or spread to other parts of my body.
  • I have already received platinum-based chemotherapy and PD-1/PD-L1 therapy.
  • I am well enough to participate with a performance status of 0 or 1.
  • I have measurable cancer that can be seen on imaging tests.

You may not be able to join if

  • I have uterine sarcomas or uterine neuroendocrine carcinoma.
  • My endometrial cancer came back more than 12 months after my last platinum therapy without more platinum treatment.
  • I have received treatment that included a TOP1 inhibitor.
  • I have received treatment with puxitatug samrotecan or a B7-H4 targeting agent before.
  • I have a history of lung issues that required steroids or current lung problems.
  • I have serious lung problems from other conditions.
  • I have active autoimmune or inflammatory disorders.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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 Locations
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Eligibility 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 chemothe…
Contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

CONTACT