Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Puxitatug Samrotecan · 1 trial · 2 indications
PFS is defined as the time from randomization until progression per RECIST 1.1 as assessed by BICR or death due to any cause.
OS is defined as the time from randomization until the date of death due to any cause.
| Arm | Type | Description |
|---|---|---|
| Puxitatug Samrotecan | EXPERIMENTAL | Puxi-Sam IV (intravenous) Q3W . |
| Chemotherapy | ACTIVE_COMPARATOR | Physician's choice of chemotherapy Doxorubicin IV Q3W or Paclitaxel IV on Days 1, 8, and 15 in 28 day cycles. |
| Name | Type | Description |
|---|---|---|
| Puxitatug Samrotecan | DRUG | 2.4 mg/kg on Day 1 Q3W Route of administration: IV infusion |
| Doxorubicin | DRUG | 60 mg/m2 on Day 1 Q3W Route of administration: IV |
| Paclitaxel | DRUG | 80 mg/m2 on Days 1, 8, and 15 in 28-day cycle Route of Administration: IV |
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...
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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.
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.
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.
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.
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.
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.