ClinicaliQ Trial Snapshot
- Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) — Recruiting • Phase III • Oncology • NCT07044336.
- Treatment being tested: Puxitatug samrotecan (AZD8205), a novel B7-H4-directed antibody-drug conjugate, compared against standard chemotherapy (doxorubicin or paclitaxel) in a Phase III randomized trial for B7-H4-positive advanced/metastatic endometrial cancer.
- Patient eligibility overview: Adults with advanced or metastatic endometrial cancer that has progressed after platinum-based chemotherapy, with confirmed B7-H4 expression selected as the biomarker for treatment allocation.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.