ACTION: Abiraterone in Combination with Tildrakizumab
Research type
Research Study
Full title
ACTION: Phase I/II Trial of Abiraterone Acetate in Combination with Tildrakizumab (anti-IL23 targeting monoclonal antibody) in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC)
IRAS ID
271212
Contact name
Johann De Bono
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2019-003485-40
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The purpose of this study is to find out the side effects and safety of a combination of the anti-IL23 targeting monoclonal antibody tildrakizumab in combination with abiraterone acetate in men with metastatic castration resistant prostate cancer and to determine the most appropriate dose of this combination. In the Phase I part of this study small groups of patients will be treated with increasing doses of tildrakizumab in combination with a fixed dose of abiraterone acetate(1000mg once daily). Once Phase I has been completed the combination with the optimum safety and pharmacokinetic/pharmacodynamic profile will be taken forward to the Phase II part of the study. The Phase II part of the study will evaluate the optimized dose/schedule identified in Phase I of the study in patients with metastatic castration resistant prostate cancer.
Summary of Results:
All Phase I dose levels had been investigated but no toxicity was seen. The investigation of a higher Phase I dose level was suggested however early termination meant this could not be implemented. All Phase I PK/PD data analysis would be carried out for completeness in order to give a clear report of our findings.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
20/EE/0189
Date of REC Opinion
1 Oct 2020
REC opinion
Further Information Favourable Opinion