Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in 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)

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Investigational drug late phase More information Active drug More information Moderate burden on patient More information

Trial Details

Sponsor: AstraZeneca (industry)

Phase: 3

Start date: Aug. 1, 2025

Planned enrollment: 700

Trial ID: NCT07044336
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More trial details at ClinicalTrials.gov More info

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Investigational Drug AI Analysis

chevron Show for: AZD8205 (puxitatug samrotecan)

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Goal: To determine whether the B7-H4–targeted antibody-drug conjugate puxitatug samrotecan (AZD8205) improves progression-free survival and overall survival compared with physician’s choice single-agent chemotherapy in previously treated advanced/metastatic endometrial cancer, and to assess symptomatic and quality-of-life outcomes.

Patients: Adults with histologically confirmed endometrial carcinoma or carcinosarcoma that is recurrent/metastatic, B7-H4–selected, and has progressed on or after platinum-based chemotherapy and anti–PD-1/PD-L1 therapy (sequentially or in combination). Up to two prior systemic lines in the advanced/metastatic setting are permitted. ECOG performance status 0–1 and measurable disease by RECIST 1.1 are required. Key exclusions include uterine sarcomas or neuroendocrine carcinoma, late (>12 months) recurrence after curative-intent platinum without subsequent platinum at recurrence, prior TOP1 inhibitor–containing therapy or B7-H4–directed agents, history or current ILD/pneumonitis, significant pulmonary compromise, and active autoimmune/inflammatory disorders.

Design: Global, multicenter, randomized, open-label, phase III, two-arm study with 1:1 allocation to experimental ADC versus physician’s choice chemotherapy. Approximately 700 eligible participants.

Treatments: Experimental arm: puxitatug samrotecan (AZD8205) intravenous Day 1 every 3 weeks. AZD8205 is a B7-H4–directed antibody-drug conjugate linking a human anti–B7-H4 antibody to a cleavable topoisomerase I inhibitor payload. After binding B7-H4 on tumor cells, the ADC is internalized and releases the TOP1 inhibitor to disrupt DNA replication and induce cell death. Early phase data in heavily pretreated solid tumors have shown manageable toxicity and preliminary activity, including partial responses in ovarian, breast, and endometrial cancers. Control arm: physician’s choice single-agent chemotherapy with doxorubicin IV every 3 weeks or paclitaxel IV on Days 1, 8, and 15 of 28-day cycles, both consistent with standard options in this setting.

Outcomes: Primary endpoints: progression-free survival by BICR per RECIST 1.1 and overall survival. Key secondary endpoints: overall response rate, duration of response, PFS2, time to first and second subsequent anticancer therapy (TFST, TSST), time to treatment discontinuation (any reason), and time to worsening of endometrial cancer symptoms, physical functioning, and health-related quality of life using selected EORTC items. Assessment window is approximately 3 years.

Burden on patient: Moderate. Treatment is intravenous in both arms with visit frequency every 3 weeks for AZD8205 and either every 3 weeks for doxorubicin or weekly 3-of-4 weeks for paclitaxel, which can increase chair time and travel in the paclitaxel cohort. As a phase III trial, procedures will include regular imaging per RECIST 1.1 and standard safety labs; extensive pharmacokinetic sampling or mandatory biopsies are not described, suggesting no added intensive research procedures beyond routine oncology care. Patients with pulmonary risk factors are excluded, which limits additional pulmonary monitoring needs, though standard monitoring for ADC and cytotoxic toxicities (hematology, chemistry, and symptom assessments) will apply. Overall burden aligns with standard IV therapy trials with scheduled scans and clinic visits.

Last updated: Oct 2025

Eligibility More information

Caution: ClinicalTrials.gov appears to have newer eligibility criteria than the version saved here. Review the current criteria in ClinicalTrials.gov.

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Status: Not yet recruiting

Research Site

Witten, 58452, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Ulm, 89075, Germany

No email / No phone

Status: Not yet recruiting

Research Site

Athens, 11528, Greece

No email / No phone

Status: Not yet recruiting

Research Site

Athens, 14564, Greece

No email / No phone

Status: Not yet recruiting

Research Site

Budapest, 1122, Hungary

No email / No phone

Status: Not yet recruiting

Research Site

Budapest, 1082, Hungary

No email / No phone

Status: Not yet recruiting

Research Site

Győr, 9024, Hungary

No email / No phone

Status: Not yet recruiting

Research Site

Debrecen, 4032, Hungary

No email / No phone

Status: Not yet recruiting

Research Site

Ashdod, 7747629, Israel

No email / No phone

Status: Not yet recruiting

Research Site

Ramat Gan, 5262000, Israel

No email / No phone

Status: Not yet recruiting

Research Site

Alessandria, 15121, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Aviano, 33081, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Bologna, 40138, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Catania, 95126, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Florence, 50134, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Haifa, 34362, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Milan, 20132, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Milan, 20141, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Milan, 20159, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Milan, 20162, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Milan, 35128, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Monza, 20900, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Naples, 80131, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Parma, 43126, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Pisa, 56100, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Ponderano, 13875, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Roma, 00168, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Torino, 10128, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Vicenza, 36100, Italy

No email / No phone

Status: Not yet recruiting

Research Site

Chūōku, 104-0045, Japan

No email / No phone

Status: Not yet recruiting

Research Site

Nakagami-gun, 903-0215, Japan

No email / No phone

Status: Not yet recruiting

Research Site

Vilnius, 08661, Lithuania

No email / No phone

Status: Not yet recruiting

Research Site

Kaunas, LT50009, Lithuania

No email / No phone

Status: Not yet recruiting

Research Site

Amsterdam, 1081 HV, Netherlands

No email / No phone

Status: Not yet recruiting

Research Site

Maastricht, 6202 AZ, Netherlands

No email / No phone

Status: Not yet recruiting

Research Site

Siedlce, 08-110, Poland

No email / No phone

Status: Not yet recruiting

Research Site

Lodz, 93-338, Poland

No email / No phone

Status: Not yet recruiting

Research Site

Singapore, 217562, Singapore

No email / No phone

Status: Not yet recruiting

Research Site

Singapore, 119082, Singapore

No email / No phone

Status: Not yet recruiting

Research Site

Maribor, 2000, Slovenia

No email / No phone

Status: Not yet recruiting

Research Site

Ljubljana, 1000, Slovenia

No email / No phone

Status: Not yet recruiting

Research Site

Barcelona, 8025, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Badalona, 8916, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Valencia, 46010, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Madrid, 28041, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Hospitalet DEL Llobregat, 8908, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Córdoba, 14004, Spain

No email / No phone

Status: Not yet recruiting

Research Site

Northwood, HA6 2RN, United Kingdom

No email / No phone

Status: Not yet recruiting

Research Site

London, E1 1BB, United Kingdom

No email / No phone

Status: Not yet recruiting

Research Site

Derby, DE22 3NE, United Kingdom

No email / No phone

Status: Not yet recruiting

Research Site

Tucson, Arizona, 85719, United States

No email / No phone

Status: Not yet recruiting

Research Site

Los Angeles, California, 90095, United States

No email / No phone

Status: Not yet recruiting

Research Site

Miami, Florida, 33136, United States

No email / No phone

Status: Not yet recruiting

Research Site

Honolulu, Hawaii, 96826, United States

No email / No phone

Status: Not yet recruiting

Research Site

Chicago, Illinois, 60607, United States

No email / No phone

Status: Not yet recruiting

Research Site

Urbana, Illinois, 61801, United States

No email / No phone

Status: Not yet recruiting

Research Site

Fort Wayne, Indiana, 46845, United States

No email / No phone

Status: Not yet recruiting

Research Site

Baltimore, Maryland, 21201, United States

No email / No phone

Status: Not yet recruiting

Research Site

Detroit, Michigan, 48201, United States

No email / No phone

Status: Not yet recruiting

Research Site

Ann Arbor, Michigan, 48109, United States

No email / No phone

Status: Not yet recruiting

Research Site

Camden, New Jersey, 08103, United States

No email / No phone

Status: Not yet recruiting

Research Site

The Bronx, New York, 10461, United States

No email / No phone

Status: Not yet recruiting

Research Site

Brooklyn, New York, 11220, United States

No email / No phone

Status: Not yet recruiting

Research Site

Greenville, North Carolina, 27834, United States

No email / No phone

Status: Not yet recruiting

Research Site

Cleveland, Ohio, 44109, United States

No email / No phone

Status: Not yet recruiting

Research Site

Hilliard, Ohio, 43026, United States

No email / No phone

Status: Not yet recruiting

Research Site

Sylvania, Ohio, 43560, United States

No email / No phone

Status: Not yet recruiting

Research Site

Portland, Oregon, 97239, United States

No email / No phone

Status: Not yet recruiting

Research Site

York, Pennsylvania, 17403, United States

No email / No phone

Status: Not yet recruiting

Research Site

Pittsburgh, Pennsylvania, 15213, United States

No email / No phone

Status: Not yet recruiting

Research Site

Pittsburgh, Pennsylvania, 15224, United States

No email / No phone

Status: Not yet recruiting

Research Site

Willow Grove, Pennsylvania, 19090, United States

No email / No phone

Status: Not yet recruiting

Research Site

Hershey, Pennsylvania, 17033, United States

No email / No phone

Status: Not yet recruiting

Research Site

Sioux Falls, South Dakota, 57104, United States

No email / No phone

Status: Not yet recruiting

Research Site

Nashville, Tennessee, 37232, United States

No email / No phone

Status: Not yet recruiting

Research Site

Houston, Texas, 77030, United States

No email / No phone

Status: Not yet recruiting

Research Site

Seattle, Washington, 98104, United States

No email / No phone

Status: Not yet recruiting

Research Site

Kennewick, Washington, 99336, United States

No email / No phone

Status: Not yet recruiting

Research Site

Waukesha, Wisconsin, 53188, United States

No email / No phone

Status: Not yet recruiting

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