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Puxitatug Samrotecan

Phase 3

Endometrial Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jul 29, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment800

FDA Designations

No designations recorded

Clinical trial landscape

Puxitatug Samrotecan · 1 trial · 2 indications

Phase 3 1
NCT07044336Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)Endometrial Cancer
RECRUITING800 Analytics
PHASE3RECRUITING
Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)
Endometrial CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression Free Survival (PFS) for Arm A vs Arm B
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
Approximately 3 years

OS is defined as the time from randomization until the date of death due to any cause.

Secondary Endpoints

Assessment of Overall Response Rate (ORR) for Arm A vs Arm B
Approximately 3 years
Assessment of Duration of response (DoR) for Arm A vs Arm B
Approximately 3 years
Assessment of progression-free survival 2 (PFS2) for Arm A vs Arm B
Approximately 3 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Puxitatug SamrotecanEXPERIMENTALPuxi-Sam IV (intravenous) Q3W .
ChemotherapyACTIVE_COMPARATORPhysician's choice of chemotherapy Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles.

Interventions

NameTypeDescription
Puxitatug SamrotecanDRUG2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion
DoxorubicinDRUG60 mg/m2 on Day 1 Q3W Route of administration: IV
PaclitaxelDRUG80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites320

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 chemothe...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChinaCzechiaDenmarkFinlandFranceGeorgiaGermanyGreeceHungaryIsraelItalyJapanLithuaniaNetherlandsPolandSingaporeSloveniaSouth KoreaSpainTaiwanUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJul 29, 2026NCT07044336lastUpdatePostDate: changed
LOWJul 29, 2026NCT07044336lastUpdatePostDate: changed
LOWJun 10, 2026NCT07044336Enrollment: 700 → 800
LOWJun 10, 2026NCT07044336Enrollment: 700 → 800

Frequently asked questions about Puxitatug Samrotecan

What is Puxitatug Samrotecan used for in endometrial cancer?

Puxitatug Samrotecan is an investigational oncology drug being studied for the treatment of endometrial cancer. It is currently in Phase 3 clinical development as a monotherapy compared against chemotherapy in patients with B7-H4-selected endometrial cancer. The drug is being evaluated in the Bluestar-Endometrial01 trial.

What does Puxitatug Samrotecan target?

Puxitatug Samrotecan targets B7-H4, a protein expressed in certain tumors. The Phase 3 trial specifically enrolls patients with B7-H4-selected endometrial cancer, indicating the drug is designed to act on tumors that express this biomarker. The drug is being studied as a monotherapy in this patient population.

Who is developing Puxitatug Samrotecan?

Puxitatug Samrotecan is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting a Phase 3 clinical trial of the drug in endometrial cancer.

What phase is Puxitatug Samrotecan in?

Puxitatug Samrotecan is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The drug is being evaluated in a randomized, active-controlled trial in patients with B7-H4-selected endometrial cancer.

What clinical trials is Puxitatug Samrotecan in?

Puxitatug Samrotecan is being studied in the Phase 3 clinical trial NCT07044336, titled 'Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)'. This trial is currently recruiting participants and has an estimated enrollment of 800 patients.

Is Puxitatug Samrotecan the same as AZD8205?

Yes, Puxitatug Samrotecan is also known as AZD8205. The Phase 3 clinical trial NCT07044336 uses the name AZD8205 in its title, confirming that both names refer to the same investigational drug being developed by AstraZeneca for endometrial cancer.