Clinical Trials List
2025-12-27 - 2032-05-15
Phase III
Not yet recruiting3
ICD-10C54.8
Malignant neoplasm of overlapping sites of corpus uteri
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9182.8
Malignant neoplasm of other specified sites of body of uterus
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)
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Sponsor
-
Trial scale
Multi-Regional Multi-Center
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Update
2026/06/03
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Solution
Infusion solution
Infusion solution
Active Ingredient
IV Bag Protectant
Doxorubicin
Paclitaxel
Dosage Form
376
27C
27C
Dosage
1 ml Labeled Vial
50mg 25ml (2mg/ml)
6mg/ml 100mg
Endpoints
The superiority of AZD8205 over physician-selective chemotherapy was demonstrated by evaluating overall survival (OS) in B7-H4 selective advanced/metastatic EC patients.
Inclution Criteria
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
Exclusion Criteria
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 Puxi-Sam 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
Gender-based Eligibility
The Estimated Number of Participants
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Taiwan
10 participants
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Global
700 participants
