Recruiting NCT07044336

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

Phase III Interventional Endometrial Cancer Malignant Solid Tumour

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Puxitatug Samrotecan, Doxorubicin, Paclitaxel.
Who it may be relevant to: Registry conditions: Endometrial Cancer, Malignant Solid Tumour. Basic parameters: from 18 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +23
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

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.

Detailed 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 Puxi-Sam (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 Puxi-Sam 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 cycle (Arm B).

This study aims to see if Puxi-Sam 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.

Interventions

Drug Puxitatug Samrotecan
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
Drug Doxorubicin
60 mg/m2 on Day 1 Q3W Route of administration: IV
Drug Paclitaxel
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV

Primary outcome measures

Progression Free Survival (PFS) for Arm A vs Arm B [Time frame: Approximately 3 years]
Overall survival (OS) for Arm A vs Arm B [Time frame: Approximately 3 years]

Secondary outcome measures (7)

Assessment of Overall Response Rate (ORR) for Arm A vs Arm B [Time frame: Approximately 3 years]
Assessment of Duration of response (DoR) for Arm A vs Arm B [Time frame: Approximately 3 years]
Assessment of progression-free survival 2 (PFS2) for Arm A vs Arm B [Time frame: Approximately 3 years]
Time until first subsequent anticancer therapy after discontinuation of the randomized treatment, or death (TFST) for Arm A vs Arm B [Time frame: Approximately 3 years]
Time until the second subsequent anticancer therapy after discontinuation of the first subsequent treatment, or death (TSST) for Arm A vs Arm B [Time frame: Approximately 3 years]
Time until discontinuation of treatment for any reason, or death (TDT) for Arm A vs Arm B [Time frame: Approximately 3 years]
Worsening in endometrial symptoms for Arm A vs Arm B [Time frame: Approximately 3 years]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Treatment