BLUESTAR-Endometrial01
Research type
Research Study
Full title
A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician’s Choice of Chemotherapy in Participants with B7 H4-Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (BLUESTAR-Endometrial01)
IRAS ID
1011823
Contact name
Sarah Liddle
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2024-518777-34
Research summary
Researchers are looking for a better way to treat advanced or metastatic endometrial cancer. This cancer starts in the lining of the womb. Advanced or metastatic means that the cancer has grown outside of the womb or spread to other parts of the body and cannot be treated by surgery. Common treatments for advanced or metastatic endometrial cancer include chemotherapy and immunotherapy drugs designed to help the immune cells stop tumours from growing, but these do not always work well and better treatments are required when these fail.
This trial is aiming to see whether a new drug AZD8205, also called puxitatug samrotecan, may work better than more standard chemotherapy. AZD8205 is designed to attach to a protein called B7-H4 on the surface of cancer cells and deliver chemotherapy direct to kill that cell as well as surrounding tumour cells. B7-H4 is found at high levels on certain types of tumours including endometrial cancer, so researchers think that AZD8205 could help stop endometrial cancers grow.
This study includes 4 phases: Pre-Screening in which a sample of the participant’s cancer tissue is tested for B7-H4, Screening to ensure that it is safe and appropriate for the participant to receive trial treatment, Treatment and Follow-up.
Participants who receive treatment will be randomised equally to AZD8205 (Arm A) or physician’s choice of standard chemotherapy (Arm B; doxorubicin or paclitaxel). AZD8205 and doxorubicin are given once every 3 weeks and paclitaxel once a week for three weeks out of four.
The total number of cycles of treatment given and how long participants will be in the study will depend on factors such as their tolerance of treatment and how effective this is in controlling their cancer.
The total study size will be approximately 700 eligible participants and it is designed to assess whether participants treated with AZD8205 live longer before their cancer worsens than those treated with standard chemotherapy.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
26/EM/0002
Date of REC Opinion
29 Dec 2025
REC opinion
Favourable Opinion