AstraZeneca Initiates Phase 1/2 Clinical Trial of STEAP2-Targeted ADC AZD0516 in Advanced Prostate Cancer

▎Armstrong

On September 18, 2025, AstraZeneca registered a Phase I clinical trial, SEACLIFF, for AZD0516 monotherapy or combination therapy in advanced prostate cancer on the Clinicaltrials.gov website.

This Phase 1/2 clinical trial plans to enroll 177 patients with advanced prostate cancer, focusing on combination therapy with the PARP1 inhibitor AZD9574, and is expected to be completed in January 2029.

At this year's AACR conference, AstraZeneca reported preclinical research data on AZD0516. AZD0516 uses TOP1i exatecan as the Payload and demonstrated sustained tumor-killing effects in CDX and PDX models.

Summary

AstraZeneca, in collaboration with Daiichi Sankyo, has introduced DS-8201 and Dato-DXd, while also establishing its own TOP1i ADC technology platform. In the field of prostate cancer, the PSMA target has completed Proof of Concept (POC). Amgen's STEAP1/CD3 bispecific antibody and Johnson & Johnson's KLK2/CD3 bispecific antibody have advanced to Phase III clinical trials. Janux and Vir's PSMA/CD3 bispecific antibodies have also shown excellent efficacy potential in early clinical trials. AstraZeneca is the first to develop a STEAP2 ADC and advance it to the clinical stage.