A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)

Trial ID # NCT05123482
Phase I/IIa
Drug Class Antibody Drug Conjugates: B7H4
Drug Name Puxitatug samrotecan
Alternate Drug Names AZD8205
Drugs in Trial Puxitatug samrotecan
Eligible Participant

Advanced solid tumors

Patients Enrolled

47 patients in dose escation, median 5 prior therapies (2-9); 17 OC

Therapy Setting

Recurrence

Efficacy

ORR: 17.6% (3PR)
DCR: 70.6% (3PR, 9SD)

Conclusion

Puxitatug samrotecan (AZD8205) has a manageable safety profile consistent with other Topoisomerase 1 inhibitor ADCs and shows preliminary efficacy in heavily pretreated patients with prior progression on standard treatment

Reference

Meric-Bernstam F et al. Initial results from a first-in-human study of the B7-H4- directed antibody-drug conjugate (ADC) AZD8205 (puxitatug samrotecan) in patients with advanced/metastatic solid tumors. Ann Oncol (2024) 35 (2) abstract 606O
https://www.clearityfoundation.org/wp-content/uploads/2024/11/Puxi-Sam-ESMO-2024-abstract.pdf

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