Endometrial CancerPhase 3NCT07044336

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

A Phase 3 study testing Puxitatug Samrotecan, Doxorubicin and Paclitaxel in people with Endometrial Cancer and Malignant Solid Tumour, run by AstraZeneca at 320 sites in 28 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced/metastatic EC that progressed following platinum based… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Endometrial Cancer, Malignant Solid Tumour
What is being tested?: Puxitatug Samrotecan, Doxorubicin and Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 800 participants
Where: 320 sitesin 28 countries
Study dates: 1 Aug 2025to 17 Jul 2029
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

The main inclusion criteria include but are not limited to the following:

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 exclusion criteria include but are not limited to the following:

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 received in the recurrent setting.
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

Trial locations and contacts

320 sites in 28 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Country

City, postcode or hospital

Sites recruiting now only

320 sites in 28 countries

United States69 sites, 67 recruiting

Research Site
Albuquerque, New Mexico, 87109
Recruiting
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Ann Arbor, Michigan, 48109
Not yet recruiting
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Ann Arbor, Michigan, 48197
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Austin, Texas, 78758
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Baltimore, Maryland, 21201
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Baltimore, Maryland, 21231
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Bethlehem, Pennsylvania, 18015
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Brooklyn, New York, 11220
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Camden, New Jersey, 08103
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Chicago, Illinois, 60607
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Cincinnati, Ohio, 45220
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Cleveland, Ohio, 44106
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Cleveland, Ohio, 44109
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Columbus, Ohio, 43219
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Dayton, Ohio, 45459
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Detroit, Michigan, 48201
Withdrawn
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Eugene, Oregon, 97401
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Fairfax, Virginia, 22031
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Falls Church, Virginia, 22042
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Fort Wayne, Indiana, 46845
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Greenville, North Carolina, 27834
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Hershey, Pennsylvania, 17033
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Hilliard, Ohio, 43026
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Honolulu, Hawaii, 96826
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Houston, Texas, 77030
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Indianapolis, Indiana, 46260
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Jupiter, Florida, 33458
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Kennewick, Washington, 99336
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Knoxville, Tennessee, 37920
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La Jolla, California, 92037
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Lancaster, Pennsylvania, 17601
Not yet recruiting
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Los Angeles, California, 90095
Withdrawn
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Miami, Florida, 33136
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Miami, Florida, 33176
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Miami Beach, Florida, 33140
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Minneapolis, Minnesota, 55404
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Morgantown, West Virginia, 26505
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Nashville, Tennessee, 37232
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New Port Richey, Florida, 34655
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Norfolk, Virginia, 23502
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Orange, California, 92868
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Orlando, Florida, 32806
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Paramus, New Jersey, 07652
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Peoria, Illinois, 61637
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Philadelphia, Pennsylvania, 19107
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Pinehurst, North Carolina, 28374
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Pittsburgh, Pennsylvania, 15213
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Pittsburgh, Pennsylvania, 15224
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Portland, Oregon, 97239
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Richmond, Virginia, 23298
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Roanoke, Virginia, 24016
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Scarborough, Maine, 04074
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Seattle, Washington, 98104
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Silver Spring, Maryland, 20910
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Sioux Falls, South Dakota, 57104
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Sioux Falls, South Dakota, 57105
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Stony Brook, New York, 11794
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Sylvania, Ohio, 43560
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Tampa, Florida, 33612
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The Bronx, New York, 10461
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Tucson, Arizona, 85719
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Tyler, Texas, 75702
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Urbana, Illinois, 61801
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Washington D.C., District of Columbia, 20016
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Waukesha, Wisconsin, 53188
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West Palm Beach, Florida, 33401
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White Plains, New York, 10601
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Willow Grove, Pennsylvania, 19090
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York, Pennsylvania, 17403
Not yet recruiting

Other trials in United States

China33 sites, 32 recruiting

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Beijing, 100021
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Beijing, 100026
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Beijing, 100044
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Beijing, 100730
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Changchun, 130021
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Changsha, 410011
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Changsha, 410013
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Chengdu, 610041
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Chongqing, 400030
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Dalian, 116023
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Fuzhou, 350014
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Guangzhou, 510120
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Hangzhou, 310006
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Hangzhou, 310022
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Jinan, 250012
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Jinan, 250117
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Nanchang, 330006
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Nanjing, 210004
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Shanghai, 200011
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Shanghai, 200025
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Shanghai, 200072
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Shenyang, 110004
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Shenyang, 110042
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Shenzhen, 518116
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Shijiazhuang, 050011
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Tianjin, 300060
Withdrawn
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Tianjin, 300110
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Wenzhou, 325000
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Wuhan, 430022
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Wuhan, 430030
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Xi'an, 710061
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Zhanjiang, 524001
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Zhengzhou, 450002
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Other trials in China

Brazil28 sites, 27 recruiting

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Belém, 66073-005
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Belo Horizonte, 30360-680
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Bento Gonçalves, 95700-084
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Blumenau, 89010-340
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Curitiba, 80510-130
Withdrawn
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Curitiba, 80810-050
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Florianópolis, 88020-210
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Joinville, 89201-260
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Natal, 59062-000
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Porto Alegre, 90020-090
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Porto Alegre, 90470-340
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Porto Alegre, 90610-001
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Recife, 50040-000
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Recife, 50070-480
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Recife, 52010-075
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Ribeirão Preto, 14026-040
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Rio de Janeiro, 22281-100
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Rio de Janeiro, 22775-001
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Salvador, 41950-640
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São Caetano do Sul, 09541-270
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São Paulo, 01317-000
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São Paulo, 01323-000
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São Paulo, 01323-020
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São Paulo, 01509-900
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Sorocaba, 18030-005
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Sorocaba, 18052-210
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Taubaté, 12030-200
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Teresina, 64049-200
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Other trials in Brazil

Japan21 sites, 19 recruiting

Research Site
Chūōku, 104-0045
Withdrawn
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Hidaka-shi, 350-1298
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Isehara-shi, 259-1193
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Kashiwa-shi, 277-8567
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Kōtoku, 135-8550
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Kurume-shi, 830-0011
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Matsuyama, 791-0280
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Minatoku, 105-8471
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Nagoya, 464-8681
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Nakagami-gun, 903-0215
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Niigata, 951-8510
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Okayama, 700-8558
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Osaka, 637086
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Sapporo, 003-0804
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Sapporo, 060-8638
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Sendai, 980-8574
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Suita, 565-0871
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Sunto-gun, 411-8777
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Toon-Shi, 791-0295
Active, not recruiting
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Tsu, 514-8507
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Yokohama, 236-0004
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Other trials in Japan

Italy20 sites, 20 recruiting

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Alessandria, 15121
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Aviano, 33081
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Bari, 70124
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Bologna, 40138
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Catania, 95126
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Florence, 50134
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Haifa, 34362
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Milan, 20132
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Milan, 20141
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Milan, 20159
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Milan, 20162
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Monza, 20900
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Naples, 80131
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Padova, 35128
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Parma, 43126
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Pisa, 56100
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Ponderano, 13875
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Roma, 00168
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Torino, 10128
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Vicenza, 36100
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Other trials in Italy

France18 sites, 17 recruiting

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Avignon, 84918
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Besançon, 25000
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Bordeaux, 33076
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Chambray-lès-Tours, 37170
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Cholet, 49300
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Créteil, 94010
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Grenoble, 38000
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Lille, 59000
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Limoges, 87042
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Lyon, 69008
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Nantes, 44000
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Nîmes, 30029
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Paris, 75014
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Paris, 75020
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Paris, 75900
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Plerin SUR MER, 22190
Not yet recruiting
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Rennes, 35000
Not yet recruiting
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Toulouse, 31059
Withdrawn

Other trials in France

Germany17 sites, 13 recruiting

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Amberg, 92224
Not yet recruiting
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Chemnitz, 09116
Withdrawn
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Dresden, 01307
Not yet recruiting
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Essen, 45130
Not yet recruiting
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Frankfurt am Main, 60596
Withdrawn
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Freiburg im Breisgau, 79106
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Hamburg, 20246
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Heidelberg, 69120
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Heilbronn, 74078
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Kassel, 34125
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Mainz, 55131
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Münster, 48149
Not yet recruiting
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Paderborn, 33161
Withdrawn
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Regensburg, 93053
Not yet recruiting
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Schwäbisch Hall, 74523
Withdrawn
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Ulm, 89075
Not yet recruiting
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Witten, 58452
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Other trials in Germany

Spain14 sites, 14 recruiting

Research Site
Badalona, 8916
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Barcelona, 8025
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Barcelona, 8035
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Córdoba, 14004
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El Palmar (Murcia), 30120
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L'Hospitalet de Llobregat, 8908
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Madrid, 28033
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Madrid, 28041
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Málaga, 29010
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Oviedo, 33011
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Santiago de Compostela, 15706
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Seville, 41013
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Seville, 41014
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Valencia, 46010
Not yet recruiting

Other trials in Spain

Israel10 sites, 10 recruiting

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Ashdod, 7747629
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Hadera, 38100
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Haifa, 3109601
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Holon, 5822012
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Jerusalem, 9103102
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Jerusalem, 9112001
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Nahariya, 2210001
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Ramat Gan, 5262000
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Safed, 13100
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Tel Aviv, 6423906
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Other trials in Israel

Argentina9 sites, 9 recruiting

Research Site
Capital Federal, C1417DTB
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Ciudad Autonoma Buenos Aires, 1405
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Ciudad de Buenos Aires, C1118AAT
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Córdoba, 2356
Not yet recruiting
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Córdoba, X5004FHP
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Cuidad Autónoma de Buenos Aire, C1426ANZ
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La Rioja, 5300
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Pergamino, B2700CPM
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Viedma, R8500ACE
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Other trials in Argentina

Belgium9 sites, 9 recruiting

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Brussels, 1070
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Brussels, 1200
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Charleroi, 6000
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Edegem, 2650
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Ghent, 9000
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Leuven, 3000
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Liège, 4000
Not yet recruiting
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Liège, 4000
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Research Site
Namur, 5000
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Other trials in Belgium

United Kingdom9 sites, 8 recruiting

Research Site
Bebington, CH63 4JY
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Canterbury, CT1 3NG
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Derby, DE22 3NE
Withdrawn
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London, E1 1BB
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London, SE1 7EH
Not yet recruiting
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London, W2 1NY
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Manchester, M20 4BX
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Northwood, HA6 2RN
Not yet recruiting
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Truro, TR1 3LJ
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Other trials in United Kingdom

Czechia8 sites, 8 recruiting

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Brno, 625 00
Not yet recruiting
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Brno, 656 53
Not yet recruiting
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Hradec Králové, 500 05
Not yet recruiting
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Nový Jičín, 74101
Not yet recruiting
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Ostrava, 708 502
Not yet recruiting
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Prague, 12808
Not yet recruiting
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Prague, 180 81
Not yet recruiting
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V Uvalu 84, 150 06
Not yet recruiting

Other trials in Czechia

South Korea7 sites, 7 recruiting

Research Site
Goyang-si, 410-769
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Gwangjin-gu, 110-744
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Seoul, 03722
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Seoul, 06273
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Seoul, 135-710
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Songpa-gu, 05505
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Suwon, 16499
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Other trials in South Korea

Australia6 sites, 6 recruiting

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Malvern, 3144
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Melbourne, 3000
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Randwick, 2031
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St Leonards, 2065
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Subiaco, 6008
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Westmead, 2145
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Other trials in Australia

Canada6 sites, 6 recruiting

Research Site
Edmonton, Alberta, T6G 1Z2
Not yet recruiting
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Hamilton, Ontario, L8V 5C2
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Kingston, Ontario, K7L 2V7
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Montreal, Quebec, H2X 0C1
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Montreal, Quebec, H3T 1E2
Not yet recruiting
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Winnipeg, Manitoba, R3A 1R9
Not yet recruiting

Other trials in Canada

Taiwan5 sites, 5 recruiting

Research Site
New Taipei City, 220
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Taichung, 40705
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Tainan, 70403
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Research Site
Taipei, 100
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Taipei, 10449
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Other trials in Taiwan

Greece4 sites, 4 recruiting

Research Site
Athens, 115 28
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Athens, 11528
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Athens, 14564
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Thessaloniki, 55236
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Other trials in Greece

Hungary4 sites, 4 recruiting

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Budapest, 1082
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Budapest, 1122
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Debrecen, 4032
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Győr, 9024
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Other trials in Hungary

Austria3 sites, 3 recruiting

Research Site
Graz, 8036
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Innsbruck, 6020
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Vienna, 1090
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Other trials in Austria

Finland3 sites, 3 recruiting

Research Site
Kuopio, 70210
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Tampere, 33520
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Turku, 20520
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Other trials in Finland

Georgia3 sites, 3 recruiting

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Batumi, 6000
Not yet recruiting
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Tbilisi, 0159
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Tbilisi, 0186
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Other trials in Georgia

Lithuania3 sites, 3 recruiting

Research Site
Kaunas, LT50009
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Vilnius, 08661
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Vilnius, 8660
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Other trials in Lithuania

Singapore3 sites, 3 recruiting

Research Site
Singapore, 119228
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Singapore, 168583
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Singapore, 217562
Not yet recruiting

Other trials in Singapore

Denmark2 sites, 2 recruiting

Research Site
Herlev, 2730
Not yet recruiting
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Odense, 5000
Not yet recruiting

Other trials in Denmark

Netherlands2 sites, 2 recruiting

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Amsterdam, 1081 HV
Not yet recruiting
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Maastricht, 6202 AZ
Recruiting

Other trials in Netherlands

Poland2 sites, 2 recruiting

Research Site
Lodz, 93-338
Recruiting
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Siedlce, 08-110
Recruiting

Other trials in Poland

Slovenia2 sites, 2 recruiting

Research Site
Ljubljana, 1000
Not yet recruiting
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Maribor, 2000
Not yet recruiting

Other trials in Slovenia

About this study

Official title: 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)

Read the detailed description

The target population of interest in this study is participants with B7-H4-selected advanced/metastatic EC who have progressed on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 therapy, either separately or in combination and should have received no more than 2 prior lines of therapy in advanced/metastatic setting. Participants will be randomized in a 1:1 ratio to Puxi-Sam (arm A) or physician's choice of chemotherapy (arm B; doxorubicin or paclitaxel). The total study size will be approximately 700 eligible participants.

During the treatment period, participants will receive Puxi-Sam IV Day 1 Q3W (Arm A) or either doxorubicin treatment IV Day 1 Q3W or paclitaxel treatment IV on Days 1, 8, and 15 in 28-day cycle (Arm B).

This study aims to see if Puxi-Sam allows participants to live longer without their endometrial cancer getting worse, or simply to live longer, compared to participants receiving standard of care chemotherapy. This study is also looking to see how the treatment and the endometrial cancer affects participants' quality of life.

Conditions: Endometrial Cancer, Malignant Solid Tumour
Being tested: Puxitatug Samrotecan, Doxorubicin, Paclitaxel
Keywords: Bluestar-Endometrial01, AZD8205, Puxitatug Samrotecan, Puxi-Sam, Platinum-based chemotherapy, B7-H4, advanced/metastatic, Endometrial Cancer, Anti-PD-1, Anti-PD-L1, antibody-drug conjugate, Topoisomerase 1 Inhibitors, uterine neoplasm, female urogenital neoplasm
Medical subject headings: Endometrial Neoplasms, Neoplasm Metastasis, Uterine Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Puxitatug SamrotecanDrug
Also called Puxi-Sam
2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
DoxorubicinDrug
Also called ADRIAMYCIN®
60 mg/m2 on Day 1 Q3W Route of administration: IV
PaclitaxelDrug
Also called TAXOL®
80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV

Study groups in NCT07044336
Study group	Role	What they receive
Puxitatug Samrotecan	Experimental	Puxi-Sam IV (intravenous) Q3W . Receives: Drug: Puxitatug Samrotecan
Chemotherapy	Active comparator	Physician's choice of chemotherapy Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles. Receives: Drug: Doxorubicin; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival (PFS) for Arm A vs Arm B
PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Measured: Approximately 3 years
Overall survival (OS) for Arm A vs Arm B
OS is defined as the time from randomization until the date of death due to any cause.
Measured: Approximately 3 years

Secondary outcomes (7)

Assessment of Overall Response Rate (ORR) for Arm A vs Arm B
ORR is defined as the proportion of participants who have a response of CR or PR, as determined by BICR assessments, per RECIST 1.1.
Measured: Approximately 3 years
Assessment of Duration of response (DoR) for Arm A vs Arm B
DoR will be defined as the time from the date of first documented response until the date of documented progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
Measured: Approximately 3 years
Assessment of progression-free survival 2 (PFS2) for Arm A vs Arm B
PFS2 will be defined as the time from randomization to the earliest of the progression event (following the initial Investigator-assessed progression), after first subsequent therapy, or death.
Measured: Approximately 3 years
Time until first subsequent anticancer therapy after discontinuation of the randomized treatment, or death (TFST) for Arm A vs Arm B
TFST is defined as the time from randomization until the start date of the first subsequent anticancer therapy after discontinuation of the randomized treatment, or death due to any cause.
Measured: Approximately 3 years
Time until the second subsequent anticancer therapy after discontinuation of the first subsequent treatment, or death (TSST) for Arm A vs Arm B
TSST is defined as the time from randomization until the start date of the second subsequent anticancer therapy after discontinuation of the first subsequent treatment, or death due to any cause.
Measured: Approximately 3 years
Time until discontinuation of treatment for any reason, or death (TDT) for Arm A vs Arm B
TDT is defined as the time from randomization until discontinuation of treatment for any reason, including disease progression, toxicity, and death.
Measured: Approximately 3 years
Worsening in endometrial symptoms for Arm A vs Arm B
Time to worsening is defined as time from date of randomization to the date of worsening while on treatment for endometrial symptoms, physical functioning, and health-related quality of life based on select items from the EORTC IL389.
Measured: Approximately 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202517 Jul 2029

First posted30 Jun 2025
Study start1 Aug 2025
Primary completion15 Oct 2027 (estimated)
Study completion17 Jul 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Endometrial CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Single Open-Label
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 800 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07044336
Sponsor's protocol ID: D6900C00003
Other IDs: GOG-3110, ENGOT-en28
Status last verified: Jul 2026
First submitted: 23 Jun 2025
Last updated: 29 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Interested in taking part?

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

All Endometrial Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT07044336
Acronym / sponsor ID: D6900C00003
Conditions: Endometrial Cancer, Malignant Solid Tumour
Keywords: Bluestar-Endometrial01, AZD8205, Puxitatug Samrotecan, Puxi-Sam, Platinum-based chemotherapy, B7-H4, advanced/metastatic, Endometrial Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 800 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 1 Aug 2025 (actual)
Primary completion: 15 Oct 2027 (estimated)
Study completion: 17 Jul 2029 (estimated)
First posted: 30 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Single Open-Label

Arm	Type	Receives
Puxitatug Samrotecan	Experimental	Drug: Puxitatug SamrotecanPuxi-Sam IV (intravenous) Q3W .
Chemotherapy	Active comparator	Drug: Doxorubicin, Drug: PaclitaxelPhysician's choice of chemotherapy Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Puxitatug SamrotecanAlso: Puxi-Sam2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion	Drug	Puxitatug Samrotecan
DoxorubicinAlso: ADRIAMYCIN®60 mg/m2 on Day 1 Q3W Route of administration: IV	Drug	Chemotherapy
PaclitaxelAlso: TAXOL®80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV	Drug	Chemotherapy

Primary outcome

Progression Free Survival (PFS) for Arm A vs Arm B
Time frame: Approximately 3 years
PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
Overall survival (OS) for Arm A vs Arm B
Time frame: Approximately 3 years
OS is defined as the time from randomization until the date of death due to any cause.

7 secondary outcomes

Assessment of Overall Response Rate (ORR) for Arm A vs Arm B
Time frame: Approximately 3 years
Assessment of Duration of response (DoR) for Arm A vs Arm B
Time frame: Approximately 3 years
Assessment of progression-free survival 2 (PFS2) for Arm A vs Arm B
Time frame: Approximately 3 years
Time until first subsequent anticancer therapy after discontinuation of the randomized treatment, or death (TFST) for Arm A vs Arm B
Time frame: Approximately 3 years
Time until the second subsequent anticancer therapy after discontinuation of the first subsequent treatment, or death (TSST) for Arm A vs Arm B
Time frame: Approximately 3 years
Time until discontinuation of treatment for any reason, or death (TDT) for Arm A vs Arm B
Time frame: Approximately 3 years
Worsening in endometrial symptoms for Arm A vs Arm B
Time frame: Approximately 3 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Related trials for Endometrial Cancer

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

Brian Slomovitz, MD principal investigator

Icahn School of Medicine at Mount Sinai

Stephanie Gaillard, MD, PhD principal investigator

Johns Hopkins University - Sidney Kimmel Comprehensive Cancer Center (SKCCC)

Nicole Concin, Prof. principal investigator

Head of the Division of General Gynecology and Gynecologic Oncology at the Department of Obstetrics and Gynecology of MedUni Vienna and University

320 sites in 28 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Puxitatug Samrotecan, Doxorubicin and Paclitaxel in people with Endometrial Cancer and Malignant Solid Tumour, run by AstraZeneca at 320 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 320 sites in United States, China, Brazil, Japan, Italy and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) for Arm A vs Arm B (time frame: Approximately 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07044336.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.