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
AstraZeneca
Summary
This study is being conducted to learn more about the safety, tolerability, and effectiveness of an experimental treatment for metastatic prostate cancer called AZD6621. The study is split into different modules which will look at AZD6621 delivered by different methods. The study is also further split into 2 parts, Part A which will test different dose levels of AZD6621 to determine which doses are the best in terms of safety and side effects (dose escalation), and Part B will further test at least two AZD6621 doses in a larger group of participants (dose expansion).
Description
This is a first in human, modular, Phase I/II, open-label, multicenter study of AZD6621, in adult participants with metastatic prostate cancer. The study will consist of study modules, each evaluating safety, tolerability, PK, pharmacodynamics, and anti-tumor activity of AZD6621 in metastatic prostate cancer. The study will also characterize the PK and immunogenicity of AZD6621.
Eligibility
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria 1. Capable of giving signed informed consent and complying to the study protocol. 2. Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form. 3. ≥ 18 years of age at the time of signing the informed consent form. 4. Participants with: 1. Histologically confirmed diagnosis of metastatic adenocarcinoma of the prostate 2. Surgically or medically castrated, with serum testosterone levels ≤ 50 ng/dL (≤ 1.75 nmol/L) ≤ 28 days before first dose of study intervention. Participants without prior surgical castration must be curr…
Interventions
- DrugAZD6621
A T Cell-engaging Antibody that targets STEAP2, CD3, and CD8
Locations (25)
- Research SiteOrlando, Florida
- Research SiteTampa, Florida
- Research SiteBoston, Massachusetts
- Research SiteGrand Rapids, Michigan
- Research SiteCommack, New York
- Research SiteProvidence, Rhode Island