Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4 Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)
AstraZeneca
Summary
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.
Description
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 P…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
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…
Interventions
- DrugPuxitatug Samrotecan
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
- DrugDoxorubicin
60 mg/m2 on Day 1 Q3W Route of administration: IV
- DrugPaclitaxel
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
Locations (307)
- Research SiteTucson, Arizona
- Research SiteLa Jolla, California
- Research SiteLos Angeles, California
- Research SiteOrange, California
- Research SiteJupiter, Florida
- Research SiteMiami, Florida