An official website of the United States government
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
Trial Status: active
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.
Inclusion 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 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07044336.
Locations matching your search criteria
United States
California
Orange
UC Irvine Health/Chao Family Comprehensive Cancer Center
Status: Active
Name Not Available
Maryland
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center