NCT04458311: ACTIon

Abiraterone Acetate in Combination With Tildrakizumab

Terminated Phase 1, PHASE2 Last updated 25 April 2024

What this trial tests

Phase 1, PHASE2 trial testing Abiraterone Acetate in Metastatic Castration Resistant Prostate Cancer in 13 participants. Terminated before completion.

Timeline

1 December 2020

Primary endpoint
1 April 2023

15 November 2023

Quick facts

Lead sponsor	Institute of Cancer Research, United Kingdom
Phase	Phase 1, PHASE2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	13
Start date	1 December 2020
Primary completion	1 April 2023
Estimated completion	15 November 2023
Sites	6 locations across United Kingdom, Switzerland

Drugs / interventions tested

• Abiraterone Acetate (ABIRATERONE) — full drug profile →
• Tildrakizumab (TILDRAKIZUMAB) — full drug profile →

Conditions studied

• Metastatic Castration Resistant Prostate Cancer — all drugs for Metastatic Castration Resistant Prostate Cancer →

Sponsor

Institute of Cancer Research, United Kingdom

Who can join

18 and older, male only, with Metastatic Castration Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 (500mg 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interleukins in cancer: from biology to therapy.
   Briukhovetska D, Dörr J, Endres S, Libby P, et al · · 2021 · cited 587× · PMID 34083781 · DOI 10.1038/s41568-021-00363-z
2. Dynamic prostate cancer transcriptome analysis delineates the trajectory to disease progression.
   Bolis M, Bossi D, Vallerga A, Ceserani V, et al · · 2021 · cited 91× · PMID 34857732 · DOI 10.1038/s41467-021-26840-5
3. Myeloid-Derived Suppressor Cells as Key Players and Promising Therapy Targets in Prostate Cancer.
   Siemińska I, Baran J. · · 2022 · cited 24× · PMID 35860573 · DOI 10.3389/fonc.2022.862416
4. Overcoming Immune Resistance With Radiation Therapy in Prostate Cancer.
   Mulvey A, Muggeo-Bertin E, Berthold DR, Herrera FG. · · 2022 · cited 16× · PMID 35603186 · DOI 10.3389/fimmu.2022.859785
5. Head and Neck Cancer Immunotherapy: Molecular Biological Aspects of Preclinical and Clinical Research.
   Chakraborty R, Darido C, Liu F, Maselko M, et al · · 2023 · cited 13× · PMID 36765809 · DOI 10.3390/cancers15030852
6. Redefining cancer care: harnessing circulating tumor cells' potential for improved diagnosis and prognosis.
   Janjua D, Chaudhary A, Joshi U, Tripathi T, et al · · 2025 · cited 4× · PMID 40676582 · DOI 10.1186/s12935-025-03883-y
7. Current Status of Monoclonal Antibodies-Based Therapies in Castration-Resistant Prostate Cancer: A Systematic Review and Meta-Analysis of Clinical Trials.
   Tarrar TA, Anwar MY, Ali MA, Saeed M, et al · · 2022 · cited 3× · PMID 35411277 · DOI 10.7759/cureus.22942
8. The Management of Muscle Invasive Bladder Cancer: State of the Art and Future Perspectives.
   Cigliola A, Maiorano BA, Dengur D, Tateo V, et al · · 2025 · PMID 41463264 · DOI 10.3390/cancers17244017