Puxitatug samrotecan versus chemotherapy for B7-H4–positive advanced endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III, open-label, randomized 1:1 study enrolls approximately 700 participants with B7‑H4–selected advanced or metastatic endometrial carcinoma or carcinosarcoma who progressed after platinum-based chemotherapy and anti‑PD‑1/PD‑L1 therapy. Participants receive either IV puxitatug samrotecan every 3 weeks or physician's choice of IV doxorubicin every 3 weeks or IV paclitaxel on Days 1, 8, and 15 of a 28‑day cycle. The primary aims are to determine whether puxitatug samrotecan prolongs progression-free survival or overall survival compared with standard chemotherapy, with additional evaluation of safety and patient-reported quality of life. Eligible participants must have measurable disease by RECIST 1.1, ECOG 0–1, and no more than two prior lines of therapy in the advanced/metastatic setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Research Site
  La Jolla, California, United States Recruiting
• Research Site
  Orange, California, United States Recruiting
• Research Site
  Jupiter, Florida, United States Recruiting
• Research Site
  Miami, Florida, United States Recruiting
• Research Site
  Miami Beach, Florida, United States Recruiting
• Research Site
  New Port Richey, Florida, United States Recruiting

+270 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Brian Slomovitz, MD — Icahn School of Medicine at Mount Sinai
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.