STEAP2 TCE Evaluation in Participants With Metastatic Prostate Cancer
Research type
Research Study
Full title
A Phase I/II Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD6621, a T Cell-engaging Antibody That Targets STEAP2, CD3, and CD8 in Adult Participants With Metastatic Prostate Cancer (ACTIVATED-4-PC)
IRAS ID
1013256
Contact name
Rayhan Sultan Jabir
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2025-520626-37
Clinicaltrials.gov Identifier
Research summary
This study is testing a new type of immunotherapy drug called AZD6621 in men with advanced metastatic prostate cancer that has stopped responding to hormone therapy. AZD6621 is a TCE (T cell engager), designed to connect T cells (a type of immune cell) directly to prostate cancer cells by targeting a specific marker mostly found on the surface of those cancer cells, aiming to help the immune system kill cancer more effectively with fewer side effects.
The study will find the highest safe doses of AZD6621, monitor for its side effects, and see if the drug can slow down or shrink the cancer (effectiveness). The study is conducted at multiple hospitals, is open-label, with both patients and doctors aware of what treatment is
given. The trial includes two parts: first, patients receive increasing doses of AZD6621 to find the highest safe doses, then more patients get these doses to further study safety and early effectiveness. Patients will have regular blood tests, scans (such as CT/MRI and bone scans),
and tumour sample collection to check for treatment benefit and help identify which patients might respond best.
This study will assess AZD6621’s safety and early effectiveness in prostate cancer, and help reveal how this immunotherapy works and which patients might benefit most.REC name
London - Chelsea Research Ethics Committee
REC reference
26/LO/0139
Date of REC Opinion
25 Mar 2026
REC opinion
Further Information Favourable Opinion