Trial comparing treatments 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 IV infusion (through 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
- The study aims to find out whether puxitatug samrotecan works better and is safe compared with usual chemotherapy. It also compares side‑effects of the two treatments.
- Who it's for
- Adults with advanced or metastatic endometrial cancer that has grown after platinum chemotherapy and anti‑PD‑1/PD‑L1 therapy, and whose tumors test positive for B7‑H4.
- What's involved
- Participants will be randomly assigned to receive either puxitatug samrotecan or a doctor‑chosen chemotherapy drug (doxorubicin or paclitaxel). They will have regular clinic visits for the drug infusions and for safety labs and scans.
- Time commitment
- The trial continues until the cancer progresses, with clinic visits and tests typically every few weeks over several months.
- 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
- 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.
- Has radiographically measurable disease by RECIST 1.1 The main
You likely can't join if
- 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...
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
See the full eligibility 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 The main
- 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 is enrolling
- La Jolla, California, United States
- Orange, California, 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
- West Palm Beach, Florida, 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
- Silver Spring, Maryland, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Paramus, New Jersey, United States
- Albuquerque, New Mexico, United States
+ 164 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, but 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?
This study is enrolling now at La Jolla, California, United States; Orange, California, United States; Jupiter, Florida, United States; Miami, Florida, United States; Miami Beach, Florida, United States; New Port Richey, Florida, United States and 178 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.