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Comparing an Experimental Drug Puxi-Sam to Standard Chemotherapy for Metastatic Endometrial Cancer (Bluestar‑Endometrial01)

Treatment

Phase 3 treatment study for metastatic endometrial cancer

Clinicaltrials.gov identifier:
NCT07044336

Study Contact Information:

AstraZeneca Clinical Study Information Center
📞 1‑877‑240‑9479
📧 [email protected]

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About the Study

This is a phase 3 study testing whether a new targeted drug called puxitatug samrotecan (Puxi-Sam) works better than standard chemotherapy for treating advanced or endometrial cancer which has grown or returned after prior treatment with platinum chemotherapy and an . Puxi-Sam is a type of known as an antibody-drug conjugate (ACD). ACDs are made up of an antibody attached to chemotherapy. The antibody binds to the cancer cell and delivers the chemotherapy directly into the cell. 

This Study is Open To:

People may be eligible if they have all of the following: 

  • Are 18 years or older
  • Have endometrial carcinoma or carcinosarcoma
  • Have a called B7-H4
  • Have recurrent or disease seen on scans
  • Have already received:
    • Platinum‑based chemotherapy, and
    • A type of know as PD-1 or
  • Have had no more than 2 prior treatment lines for advanced/metastatic disease
  • Have a good performance status (able to carry out daily activities)
  • Have measurable disease on imaging scans

This Study is NOT Open To:

People cannot participate if they have any of the following: 

  • Have a type of uterine cancer called uterine sarcoma or uterine neuroendocrine cancer
  • Had a late recurrence (more than 12 months) after curative platinum therapy and did not receive platinum again
  • Have previously been treated with:
    • Puxitatug samrotecan, or
    • Any other targeted therapy that targets B7-H4 cancers 
  • Have received a type of treatment called a TOP1 inhibitor
  • Have a history of serious lung inflammation (ILD or pneumonitis) or significant lung disease

What the Study Involves

Participants will be randomly assigned to one of two groups:

  • Group 1 participants will receive Puxi-Sam every 3 weeks by intravenous (IV) injection.
  • Group 2 participants will receive their doctor's choice of chemotherapy given by intravenous (IV) injection. Chemotherapy may be  which may be:
    • Doxorubicin (IV once every 3 weeks), or
    • Paclitaxel (IV weekly for 3 weeks, then 1 week off)

All participants will be followed closely while they are receiving study treatment, with regular visits, scans, and safety checks.

After treatment stops, participants will continue to be followed to track:

  • Whether the cancer worsens (progression)
  • Overall survival
  • Long‑term side effects
  • Quality of life

Study Contact Information:

AstraZeneca Clinical Study Information Center
📞 1‑877‑240‑9479
📧 [email protected]

Locations:

Florida

City: Jupiter RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

City: Miami Beach RECRUITING
Facility: Research Site
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No contact info provided

Illinois

City: Peoria RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Indiana

City: Indianapolis RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

North Carolina

City: Pinehurst RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

New Jersey

City: Paramus RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

New York

City: White Plains RECRUITING
Facility: Research Site
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No contact info provided

Ohio

City: Cincinnati RECRUITING
Facility: Research Site
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No contact info provided

City: Dayton RECRUITING
Facility: Research Site
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No contact info provided

Pennsylvania

City: Bethlehem RECRUITING
Facility: Research Site
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No contact info provided

South Dakota

City: Sioux Falls RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Tennessee

City: Knoxville RECRUITING
Facility: Research Site
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No contact info provided

Virginia

City: Roanoke RECRUITING
Facility: Research Site
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No contact info provided

West Virginia

City: Morgantown RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Other Countries

Country: Argentina
City: Capital Federal RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Country: Australia
City: Malvern RECRUITING
Facility: Research Site
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No contact info provided

Country: Australia
City: Melbourne RECRUITING
Facility: Research Site
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No contact info provided

Country: Australia
City: Randwick RECRUITING
Facility: Research Site
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No contact info provided

Country: Australia
City: St Leonards RECRUITING
Facility: Research Site
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Country: Australia
City: Subiaco RECRUITING
Facility: Research Site
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Country: Australia
City: Westmead RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Hidaka-shi RECRUITING
Facility: Research Site
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Country: Japan
City: Isehara-shi RECRUITING
Facility: Research Site
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Country: Japan
City: Kashiwa-shi RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Kurume-shi RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Kōtoku RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Matsuyama RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Minatoku RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Nagoya RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Niigata RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Okayama RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Osaka RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Sapporo RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Sapporo RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Sendai RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Suita RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Sunto-gun RECRUITING
Facility: Research Site
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Country: Japan
City: Toon-Shi RECRUITING
Facility: Research Site
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Country: Japan
City: Tsu RECRUITING
Facility: Research Site
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No contact info provided

Country: Japan
City: Yokohama RECRUITING
Facility: Research Site
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No contact info provided

Country: South Korea
City: Goyang-si RECRUITING
Facility: Research Site
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No contact info provided

Country: South Korea
City: Gwangjin-gu RECRUITING
Facility: Research Site
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No contact info provided

Country: South Korea
City: Seoul RECRUITING
Facility: Research Site
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No contact info provided

Country: South Korea
City: Seoul RECRUITING
Facility: Research Site
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Country: South Korea
City: Songpa-gu RECRUITING
Facility: Research Site
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Country: South Korea
City: Suwon RECRUITING
Facility: Research Site
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No contact info provided

Country: Taiwan
City: Tainan RECRUITING
Facility: Research Site
Contact Info:
No contact info provided

Treatment

Phase 3 treatment study for metastatic endometrial cancer

Clinicaltrials.gov identifier:
NCT07044336

Study Contact Information:

AstraZeneca Clinical Study Information Center
📞 1‑877‑240‑9479
📧 [email protected]

PRINTER FRIENDLY PAGE