Investigational Drug
AZD8205
TrialFetch AI Analysis
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Overview
Puxitatug samrotecan (AZD8205) is an investigational antibody–drug conjugate being studied in people with advanced cancers that express B7-H4, including endometrial, ovarian, breast and biliary tract cancers. Human efficacy and safety results are available from the early-phase BLUESTAR trial; a randomized phase 3 trial in endometrial cancer is also being studied. (annalsofoncology.org)
Mechanism of action
The antibody binds B7-H4 on tumor cells and delivers a topoisomerase I inhibitor payload, intended to cause DNA damage. Preclinical research describes a cleavable linker and a payload capable of affecting nearby tumor cells. (aacrjournals.org)
Efficacy
In a 2026 BLUESTAR conference abstract, objective response rates among response-evaluable patients with previously treated, B7-H4-positive cancer were 34.1% (14/41) at 2.0 mg/kg and 48.0% (24/50) at 2.4 mg/kg for endometrial cancer. For ovarian cancer, rates were 12.1% (4/33) at 1.6 mg/kg and 24.4% (11/45) at 2.4 mg/kg. Median response duration ranged from 5.8 to 7.1 months across these groups. These are early, nonrandomized results and do not establish a benefit over other treatments. (ascopubs.org)
Safety
In that analysis, grade 3 or higher treatment-related adverse events occurred in 42.9% and 47.1% of patients with endometrial cancer at 2.0 and 2.4 mg/kg, respectively; the corresponding rates in ovarian cancer were 30.3% and 75.6% at 1.6 and 2.4 mg/kg. Neutropenia and anemia were the most common severe treatment-related events. Treatment-related events led to discontinuation in one patient with endometrial cancer and five with ovarian cancer. (ascopubs.org)
Further reading
- 2026 BLUESTAR endometrial and ovarian cancer results (ascopubs.org)
- First-in-human dose-escalation results (annalsofoncology.org)
- Preclinical design and mechanism study (aacrjournals.org)
Last updated: Sep 2026
Active trials using AZD8205
Found 2 active trials using this drug:
TrialFetch AI summary: Adults with B7-H4-selected recurrent or metastatic endometrial carcinoma or carcinosarcoma that has progressed after platinum chemotherapy and anti-PD-1/PD-L1 therapy are randomized to puxitatug samrotecan or physician’s choice of doxorubicin or paclitaxel. Puxitatug samrotecan is a B7-H4-targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor payload.
ClinicalTrials.gov ID: NCT07044336
TrialFetch AI summary: Adults with relapsed or metastatic solid tumors after standard therapy, including selected breast, ovarian, biliary tract, endometrial, and squamous non-small cell lung cancers, receive AZD8205 alone or in combination with rilvegostomig and/or saruparib. AZD8205 is a B7-H4–targeted antibody–drug conjugate that delivers a topoisomerase I inhibitor payload.
ClinicalTrials.gov ID: NCT05123482
