Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07044336

This Phase III study evaluates puxitatug samrotecan vs. chemotherapy in B7-H4-selected advanced/metastatic endometrial cancer post-platinum and anti-PD-1/PD-L1 therapy. Participants, limited to 2 prior therapies, receive AZD8205 or chemotherapy (doxorubicin/paclitaxel). The trial assesses progression-free survival, overall survival, and quality of life in approximately 700 participants.

Patient Parameters

Program Overview

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 AZD8205 (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 AZD8205 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 cycles (Arm B).

This study aims to see if puxitatug samrotecan 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.

Eligibility 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 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

Locations

FACILITYZIPCITYSTATE
Research Site33458JupiterFlorida
Research Site33176MiamiFlorida
Research Site33140Miami BeachFlorida
Research Site32806OrlandoFlorida
Research Site96826HonoluluHawaii
Research Site61637PeoriaIllinois
Research Site46260IndianapolisIndiana
Research Site04074ScarboroughMaine
Research Site21201BaltimoreMaryland
Research Site21231BaltimoreMaryland

Get This Program In Your Inbox

You can sign up and apply your patients for this program.