- Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01) — Recruiting • Phase III • Oncology • NCT07044336.
- What is being tested: Puxitatug samrotecan (AZD8205), a B7-H4-targeted therapy, versus standard chemotherapy (doxorubicin or paclitaxel) in patients with advanced/metastatic endometrial cancer that has progressed after platinum-based treatment.
- Patient eligibility overview: Adults with B7-H4-positive advanced or metastatic endometrial cancer whose disease has progressed following platinum-containing chemotherapy, representing a treatment-resistant population with limited therapeutic options.
- 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.
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.
- 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.