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Abiraterone Acetate in Combination With Tildrakizumab

NCT04458311 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2024-04-25

No results posted yet for this study

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 (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.

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Interventions

DRUG

Abiraterone Acetate

Supplied as 125 mg tablets

DRUG

Tildrakizumab

Tildrakizumab will be supplied in single-use 100 mg/mL glass vials intended for IV infusion.

Sponsors & Collaborators

  • Sun Pharmaceutical Industries Limited

    collaborator INDUSTRY

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Johann De Bono, MD · National Health Service, United Kingdom

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2023-04-01
Completion
2023-11-15
FDA Drug
Yes

Countries

  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04458311 on ClinicalTrials.gov