Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer
ASpiRE: A Proof-of-mechanism and Proof-of-concept Clinical Trial Evaluating the Safety, Tolerability, Biological and Anti-tumour Activity of Apalutamide With Dual CXCR1 and CXCR2 Blockade by SX-682 for Men Suffering From Metastatic Castration-resistant Prostate Cancer (mCRPC)
Sponsor: Institute of Cancer Research, United Kingdom + Prostate Cancer UK, Janssen Pharmaceutica N.V., Belgium
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Biologically active and tolerable dose range
Time frame: From start of treatment to end of Cycle 2 Day 1 (each cycle is 28 days)
Anti-tumour activity of SX-682 when administered with Apalutamide
Time frame: 24 months
Secondary Endpoints
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%
Eligibility Criteria
Inclusion Criteria: 1. Written informed consent and be capable of cooperating with treatment. 2. Age ≥ 18 years. 3. 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. 4. 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). 5. Metastatic castration-resistant prostate cancer. 6. All patients must have documented resistance to 1 prior next generation antiandrogen therapy (NAAT) defined as: For phase 1 and phase 2 Cohorts: Patients who have progressed after either enzalutamide, Apalutamide or darolutamide (having received a minimum of 12-weeks of enzalutamide, Apalutamide or darolutamide) will enter phase 1 or phase 2 cohorts directly. Patients that have pre…
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