RecruitingPHASE3INTERVENTIONAL

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

This study is for women with advanced endometrial cancer that has come back or spread, and where previous platinum-based chemotherapy and immunotherapy haven't worked. It's a 'Phase 3' trial, which means it's testing a new drug called Puxitatug Samrotecan against standard chemotherapy (either doxorubicin or paclitaxel) to see which is more effective. 700 participants will be randomly assigned to receive either the new drug or chemotherapy. Doctors want to find out if Puxitatug Samrotecan can help patients live longer, either by slowing down the cancer's growth or by extending overall life, compared to existing treatments. The study also explores how these treatments affect a patient's quality of life.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

AstraZeneca

Enrolment target

700

Start

01 Aug 2025

Estimated completion

17 Jul 2029

Endometrial Cancer Malignant Solid Tumour

What is this study about?

This study, called Bluestar-Endometrial01, is looking into a new treatment for advanced endometrial cancer. Endometrial cancer is a type of cancer that starts in the lining of the womb. 'Advanced' means the cancer has either come back after treatment or has spread to other parts of the body. You might be interested in this study if your cancer has already been treated with certain chemotherapy drugs (platinum-based chemotherapy) and a type of immunotherapy (anti-PD-1 or anti-PD-L1 therapy), and these treatments are no longer working.

The main goal of this study is to compare a new drug called Puxitatug Samrotecan (sometimes shortened to Puxi-Sam) with standard chemotherapy. The standard chemotherapy options in this study are doxorubicin or paclitaxel, which are common treatments for this type of cancer. The researchers want to discover if Puxi-Sam can help people with endometrial cancer live longer, or if it can keep their cancer from getting worse for a longer period, compared to the current treatments.

About 700 women will take part in this study. Participants will be randomly chosen, like flipping a coin, to receive either Puxi-Sam or one of the standard chemotherapy drugs. This helps make sure the study results are fair and reliable. The study will also look at how the treatments affect your daily life and overall well-being, which is an important part of understanding new medicines.

Key takeaways

This study tests a new drug (Puxi-Sam) for advanced endometrial cancer.
It's for women whose cancer has progressed after specific previous treatments.
Participants will be randomly assigned to receive Puxi-Sam or standard chemotherapy.
The main aim is to see if Puxi-Sam helps patients live longer or delays cancer progression.
Quality of life will also be monitored during the study.

Who may be eligible?

This study is looking for women who have been diagnosed with endometrial cancer or a related type called carcinosarcoma. Your cancer needs to have come back or spread, and doctors must be able to measure it on scans.

You should have already received certain previous treatments for your advanced cancer: a platinum-based chemotherapy and an anti-PD-1 or anti-PD-L1 therapy (a type of immunotherapy). You should generally feel well enough to take part in the study, meaning your daily activities aren't too limited by your health.

There are also some reasons why you might not be able to join. For example, if you have certain other types of uterine cancer (like sarcomas or neuroendocrine cancer), or if your endometrial cancer came back more than a year after your first treatment and you haven't had further platinum-based treatment since. You also can't have previously received Puxi-Sam or similar drugs, or have specific lung problems or active autoimmune conditions.

Quick self-check

Have I been diagnosed with endometrial cancer or carcinosarcoma?
Has my cancer come back or spread, and can it be measured on a scan?
Have I already received platinum-based chemotherapy and anti-PD-1/PD-L1 immunotherapy for my advanced cancer?
Do I generally feel well and able to carry out most daily activities?
Do I have any serious ongoing lung problems or autoimmune conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will be randomly assigned to one of two groups. One group will receive the new drug, Puxitatug Samrotecan (Puxi-Sam), which is given into a vein (intravenously, or IV) on the first day of a 3-week cycle. The other group will receive standard chemotherapy, which will either be doxorubicin (given IV on day 1 of a 3-week cycle) or paclitaxel (given IV on days 1, 8, and 15 of a 4-week cycle).

You will have regular appointments and tests, such as blood tests and scans, to check how you're responding to the treatment and to monitor for any side effects. The study will continue for as long as the treatment is helping you. Even after you stop the main treatment, you'll have follow-up visits to see how you're doing. The total length of your participation will depend on how you respond to the treatment and the follow-up schedule.

Potential risks and benefits

Taking part in a clinical trial can offer potential benefits, such as access to a new treatment before it's widely available, which might be more effective than current options for your specific cancer. You'll also receive close medical attention and monitoring. However, there are also potential risks; Puxi-Sam is an investigational drug, meaning its full range of side effects and benefits are still being studied. Like all cancer treatments, both Puxi-Sam and the standard chemotherapy drugs can have side effects, which your doctor will discuss with you. You have the right to leave the study at any time, for any reason, without it affecting your future medical care.

Locations (314)

Research Site
Tucson, United States· Not yet recruiting
Research Site
La Jolla, United States· Recruiting
Research Site
Los Angeles, United States· Withdrawn
Research Site
Orange, United States· Recruiting
Research Site
Jupiter, United States· Recruiting
Research Site
Miami, United States· Not yet recruiting
Research Site
Miami, United States· Recruiting
Research Site
Miami Beach, United States· Recruiting
Research Site
Orlando, United States· Recruiting
Research Site
Tampa, United States· Not yet recruiting
Research Site
West Palm Beach, United States· Recruiting
Research Site
Honolulu, United States· Not yet recruiting

+302 more sites — see the official record for the full list.

Common questions

What is endometrial cancer?

Endometrial cancer is a type of cancer that starts in the lining of the uterus (womb).

What does 'advanced/metastatic' mean?

It means the cancer has either returned after initial treatment or has spread to other parts of the body.

What does 'randomized' mean?

It means you'll be assigned to a treatment group by chance, like flipping a coin, so it's fair and unbiased.

What are 'platinum-based chemotherapy' and 'anti-PD-1/PD-L1 therapy'?

These are specific types of cancer treatments that you might have already received before considering this study. Platinum-based chemotherapy is a common drug treatment, and anti-PD-1/anti-PD-L1 therapy is a type of immunotherapy that helps your own immune system fight cancer.

Can I choose which treatment I get?

No, if you join this study, you will be randomly assigned to receive either the new drug or one of the standard chemotherapy options.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.