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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
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Columbus
Ohio State University Comprehensive Cancer Center
Status: Approved
Name Not Available
Virginia
Richmond
VCU Massey Comprehensive Cancer Center
Status: Active
Name Not Available
The target population of interest in this study is participants with B7-H4-selected
advanced/metastatic EC who have progressed on or after platinum-based chemotherapy and
anti-PD-1/anti-PD-L1 therapy, either separately or in combination and should have
received no more than 2 prior lines of therapy in advanced/metastatic setting.
Participants will be randomized in a 1:1 ratio to Puxi-Sam (arm A) or physician's choice
of chemotherapy (arm B; doxorubicin or paclitaxel). The total study size will be
approximately 700 eligible participants.
During the treatment period, participants will receive Puxi-Sam IV Day 1 Q3W (Arm A) or
either doxorubicin treatment IV Day 1 Q3W or paclitaxel treatment IV on Days 1, 8, and 15
in 28-day cycle (Arm B).
This study aims to see if Puxi-Sam allows participants to live longer without their
endometrial cancer getting worse, or simply to live longer, compared to participants
receiving standard of care chemotherapy. This study is also looking to see how the
treatment and the endometrial cancer affects participants' quality of life.