Study Comparing Puxitatug Samrotecan to Chemotherapy in Advanced Endometrial Cancer
Sponsor: AstraZeneca
ClinicalTrials ID:NCT07044336
This clinical trial is testing a new drug, puxitatug samrotecan, against standard chemotherapy treatments to see which is more effective for patients with advanced endometrial cancer that has progressed after previous treatments.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study is designed to compare the effectiveness and safety of a new drug, puxitatug samrotecan, with standard chemotherapy options (doxorubicin or paclitaxel) in patients with advanced endometrial cancer. These patients have already tried platinum-based chemotherapy and anti-PD-1/anti-PD-L1 therapy, but their cancer has continued to progress. The trial will involve about 700 participants worldwide, who will be randomly assigned to receive either the new drug or one of the standard chemotherapy treatments.
Description
This study focuses on patients with advanced endometrial cancer that has continued to grow despite previous treatments. Participants will be divided into two groups: one group will receive the new drug, puxitatug samrotecan, while the other group will receive a standard chemotherapy treatment chosen by their doctor, either doxorubicin or paclitaxel. The goal is to determine if puxitatug samrotecan can help patients live longer without their cancer worsening, or simply live longer overall, compared to those receiving standard chemotherapy. The study will also assess how the treatments affect patients' quality of life. Participants will receive the new drug or chemotherapy through an IV, with the schedule depending on the treatment type. The study aims to provide valuable information on the best treatment options for advanced endometrial cancer.
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 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 AZD8205 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 33458 | Jupiter | Florida |
| Research Site | 33176 | Miami | Florida |
| Research Site | 33140 | Miami Beach | Florida |
| Research Site | 32806 | Orlando | Florida |
| Research Site | 96826 | Honolulu | Hawaii |
| Research Site | 61637 | Peoria | Illinois |
| Research Site | 46260 | Indianapolis | Indiana |
| Research Site | 04074 | Scarborough | Maine |
| Research Site | 21201 | Baltimore | Maryland |
| Research Site | 21231 | Baltimore | Maryland |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.