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Compares treatment options for Endometrial Cancer
Official title Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
ClinicalTrials.gov ID: NCT07044336
What this study is testing
What is Puxitatug Samrotecan?
Puxitatug Samrotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for endometrial cancer.
Also referred to as Puxi-Sam.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- The main 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...
- A WHO/ECOG performance status of 0 or 1 at Screening.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- The main 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
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- 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 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
+ 241 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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 and 255 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.