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Clinical Trials List

Protocol NumberD6900C00003

NCT Number(ClinicalTrials.gov Identfier)NCT07044336

Not yet recruiting

2025-12-27 - 2032-05-15

Phase III

Not yet recruiting3

Recruiting2

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)

Sponsor
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator 蕭聖謀無

Far Eastern Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 張志隆無

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yu-Fang Huang

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Chien-Hsing Lu 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator CHI-HAU CHEN CHI-HAU CHEN 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Endometrial Cancer 、Malignant Solid Tumour

Objectives

We conducted this trial to further understand the investigational drug Puxitatug Samrotecan (AZD8205) and to gain a deeper understanding of the disease under investigation (advanced/metastatic endometrial cancer) and related health issues. In this trial, AZD8205 monotherapy (using only one drug) will be compared with a physician-selected chemotherapy regimen (doxorubicin or paclitaxel) in patients with advanced/metastatic endometrial cancer who have disease progression following platinum-based chemotherapy and anti-PD-1 (Programmed Cell Death Protein 1)/anti-PD-L1 (Programmed Death-Ligand 1) therapy (either alone or in combination).

Test Drug

Frozen crystal powder for injection

Solution
Infusion solution
Infusion solution

Active Ingredient

Puxitatug samrotecan (AZD8205)
IV Bag Protectant
Doxorubicin
Paclitaxel

Dosage Form

048
376
27C
27C

Dosage

100 mg/vial
1 ml Labeled Vial
50mg 25ml (2mg/ml)
6mg/ml 100mg

Endpoints

The superiority of AZD8205 over physician-selective chemotherapy was demonstrated by evaluating progression-free survival (PFS) in B7-H4 selective advanced/metastatic EC patients.

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 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

The Estimated Number of Participants

Taiwan

10 participants
Global

700 participants