A Study of Puxitatug Samrotecan Compared to Chemotherapy for Patients with Advanced Endometrial Cancer After Previous Platinum and Immunotherapy Treatment
This study involves people with endometrial cancer that has spread to other parts of the body or has come back after previous treatment. The cancer must have a specific marker called B7-H4. People in this study have already received treatment with platinum-based chemotherapy, which is a type of cancer medicine that contains platinum, and also received treatment with anti-PD-1 or anti-PD-L1 therapy, which are medicines that help the immune system fight cancer. The study will compare a new medicine called AZD8205, also known as puxitatug samrotecan, given alone, with chemotherapy chosen by the doctor. The chemotherapy options include paclitaxel or doxorubicin, which are standard cancer medicines given through a vein.
The purpose of the study is to find out if AZD8205 works better than standard chemotherapy in slowing down cancer growth and helping people live longer. The study will look at how long people live without their cancer getting worse and how long they survive overall. It will also measure how many people respond to treatment, meaning their cancer shrinks or disappears, and how long these responses last.
During the study, people will be randomly assigned to receive either AZD8205 given through a vein or chemotherapy chosen by their doctor. AZD8205 is given as an infusion, which means it is slowly dripped into a vein over a period of time. The study will continue for several years and will track how well the treatments work and what side effects occur. People will have regular check-ups and scans to see how their cancer is responding to treatment and to monitor their overall health and quality of life.
1Random assignment to treatment group
Upon joining the study, you will be randomly assigned to one of two treatment groups. This process is called randomization.
Arm A: You will receive puxitatug samrotecan (also known as AZD8205) as the only treatment.
Arm B: Your doctor will choose one chemotherapy medication for you, either paclitaxel or doxorubicin.
2Treatment administration
The assigned medication will be given through a vein, which is called intravenous infusion.
If you are in Arm A, you will receive puxitatug samrotecan as a solution through an infusion into your vein.
If you are in Arm B, you will receive either paclitaxel or doxorubicin through an infusion into your vein, as determined by your doctor.
The specific dosage, frequency, and duration of the medication will be determined according to the study protocol.
3Regular monitoring and assessments
Throughout the study, your condition will be monitored regularly using imaging scans to check how the cancer is responding to treatment.
These assessments will follow a standard method called RECIST 1.1, which measures changes in tumor size.
Your overall health and ability to perform daily activities will be evaluated using the WHO/ECOG performance status scale.
You will be asked to complete questionnaires about your symptoms, physical functioning, and quality of life using the EORTC QL-EN24 assessment tool.
4Continuation of treatment
You will continue receiving the assigned treatment until one of the following occurs: the cancer progresses, unacceptable side effects develop, or another reason for stopping treatment arises.
The study team will monitor for disease progression, which means the cancer is growing or spreading despite treatment.
Regular assessments will be conducted by both your study doctor and independent reviewers to evaluate treatment effectiveness.
5Follow-up after treatment ends
After the assigned study treatment is discontinued, you will continue to be followed to track your health status.
Information will be collected about any additional cancer treatments you may receive after leaving the study.
The study team will monitor your overall survival and how long you remain without cancer progression.
This follow-up period will continue as specified in the study protocol.
Who Can Join the Study?
To participate in this clinical trial, you must meet the following requirements:
You must have a confirmed diagnosis of endometrial carcinoma (a type of cancer that starts in the lining of the uterus) or carcinosarcoma (a mixed type of cancer containing two different types of cancer cells) that has been verified by examining tissue under a microscope
Your cancer must have come back after treatment or spread to other parts of the body, with proof shown on imaging scans or other objective medical evidence
You must have already received treatment with platinum-based chemotherapy (a type of cancer treatment using drugs containing platinum) and anti-PD-1 or anti-PD-L1 therapy (treatments that help your immune system fight cancer), either given separately or at the same time
You must have a performance status (a measure of how well you can perform daily activities) score of 0 or 1 on the WHO/ECOG scale, meaning you are fully active or only restricted in physically demanding activities but able to carry out light work
Your cancer must be measurable on imaging scans according to specific medical guidelines called RECIST 1.1 (a standard way doctors measure tumors to track if treatment is working)
You must be an adult or elderly patient
You must be female
Who Cannot Join the Study?
The study is only for female patients. Male patients cannot participate.
The study is only for adult and elderly patients. Children and adolescents cannot participate.
Patients must have B7-H4-Selected Advanced or Metastatic Endometrial Cancer. This means the cancer must be in the lining of the uterus, must have spread beyond its original location or reached an advanced stage, and must have a specific marker called B7-H4. Patients without this specific type of cancer cannot participate.
Puxitatug Samrotecan is an investigational medication being tested in this study. It is designed to target a specific protein called B7-H4 that is found on certain cancer cells. This medication works by attaching to the B7-H4 protein and delivering a cancer-fighting substance directly to the tumor cells, which may help destroy them while limiting damage to healthy cells.
Physician’s Choice of Chemotherapy refers to standard cancer treatment medications that the doctor will select based on what is most appropriate for each patient. These are established chemotherapy drugs that are already approved and commonly used to treat endometrial cancer. The specific chemotherapy medication chosen will depend on the patient’s individual medical situation and previous treatments.
Advanced Endometrial Cancer – Endometrial cancer is a type of cancer that begins in the lining of the uterus, called the endometrium. In its advanced stage, the cancer has grown beyond the uterus and may have spread to nearby tissues or organs in the pelvic area. The disease progresses as abnormal cells in the endometrial tissue multiply uncontrollably and invade surrounding structures. Advanced endometrial cancer represents a more serious stage of the disease compared to early-stage forms that are confined to the uterus.
Metastatic Endometrial Cancer – Metastatic endometrial cancer occurs when cancer cells from the uterine lining spread to distant parts of the body through the bloodstream or lymphatic system. Common sites where the cancer may spread include the lungs, liver, bones, or lymph nodes far from the original tumor. This represents the most advanced stage of endometrial cancer, where the disease is no longer localized to the pelvic region. The cancer cells establish new tumors in these distant locations, which continue to grow and affect the function of those organs. The progression involves the cancer cells breaking away from the primary tumor, traveling through the body, and forming secondary tumors in other areas.
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