ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC).
Written informed consent and be capable of cooperating with treatment.
Age ≥ 18 years.
Histologically or biochemically confirmed adenocarcinoma of the prostate and with tumour tissue accessible for research analysis for this trial. Patients who have no histological diagnosis must be willing to undergo a biopsy to prove prostate adenocarcinoma.
Patients recruited to phase 1 dose escalation cohorts must have biopsiable disease and consent to mandatory pre- and post-treatment biopsies (baseline and on Cycle 2 Day 1).
Surgery, chemotherapy, or other anti-cancer therapy within 4 weeks prior to trial entry/randomisation into the study (with the exception of abiraterone, enzalutamide, Apalutamide or darolutamide). Any other therapy for prostate cancer, other than gonadotropin releasing hormone analogue therapy, such as progesterone, medroxyprogesterone, progestins or 5-alpha reductase inhibitors, must be discontinued at least 2 weeks before the first dose of the study drug.
Participation in another interventional clinical trial of an IMP within 4 weeks prior to trial entry. Participation in trials of licensed medications is allowed provided the medication is not a prohibited concomitant medication.
Prior limited field radiotherapy within 2 weeks and wide field radiotherapy within 4 weeks prior to trial entry.
Clinical and/or biochemical evidence of hyperaldosteronism or hypopituitarism.
Sequential
SX-682
DrugSX-682 is supplied as 100mg film coated tablets.
Apalutamide
DrugApalutamide is supplied as 60mg film coated tablets.
Biologically active and tolerable dose range
The biological active and tolerable combination doses are those that satisfy observed DLT rate\<33% and demonstrate reduction in myeloid derived suppressor cells (MDSCs).
Anti-tumour activity of SX-682 when administered with Apalutamide
Response rate on the basis of Prostate Cancer Working Group 3 (PCWG3), and/or Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Safety and tolerability profile as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Steady state pharmacokinetic parameters (CSSmin and CSSMax)
Number of patients with Prostate Specific Antigen (PSA) decline greater than 50%
Soft tissue objective response (CR or PR) by RECIST v1.1
Click on the lead sponsor to view all of their trials.
Institute of Cancer Research, United Kingdom
Lead sponsor
Prostate Cancer UK
Collaborator
Janssen Pharmaceutica N.V., Belgium
Collaborator
Oncology Institute of Southern Switzerland
Collaborator
Syntrix Biosystems, Inc.
Collaborator
Royal Marsden NHS Foundation Trust
Collaborator
Cambridge University Hospitals NHS Foundation Trust
Collaborator
Belfast Health and Social Care Trust
Collaborator
Institute of Oncology Research (IOR)
Collaborator
