Last updated 34 days ago
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
700 patients around the world
Available in Brazil, Argentina, United States
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.
AstraZeneca
10Research sites
700Patients around the world
This study is for people with
Endometrial Cancer
Requirements for the patient
From 18 Years
Female
Medical requirements
- 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.
- 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.
Sites
Instituto de Investigaciones Clínicas Córdoba
Centro de Investigación Pergamino S.A
Instituto Multidisciplinario de Oncología - CIC - Clínica Viedma, Río Negro.
Centro Médico Privado CEMAIC - Córdoba
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Fundación CENIT para la Investigación en Neurociencias
Recruiting
Sanatorio Británico - Rosario
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Hospital Alemán
Fundación Respirar
Recruiting
StudyBluestar-Endometrial01
SponsorAstraZeneca
Study typeInterventional
Conditions
Endometrial Cancer
Requirements
From 18 YearsFemale
Unique study IDclinicaltrials.gov
NCT07044336
