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

NCT07044336

RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Endometrial Cancer, Malignant Solid Tumour

Interventions: Puxitatug Samrotecan, Doxorubicin, Paclitaxel

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, China

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (320)

Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Orange, California, United States
Washington D.C., District of Columbia, United States
Jupiter, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Beach, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Peoria, Illinois, United States
Urbana, Illinois, United States
Fort Wayne, Indiana, United States
Indianapolis, Indiana, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Silver Spring, Maryland, United States
Ann Arbor, Michigan, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Camden, New Jersey, United States
Paramus, New Jersey, United States
Albuquerque, New Mexico, United States
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