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
2026/08/06
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
The Estimated Number of Participants
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Taiwan
10 participants
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Global
700 participants
