ClinicaliQ Trial Snapshot
- Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer — Recruiting • Phase I • Oncology • NCT07002320.
- Sponsor: Institute of Cancer Research, United Kingdom.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
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What This Trial Is Studying
ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC).
Eligibility Snapshot
- : 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 previously received abiraterone but not an AR antagonist should receive a lead-in with Apalutamide on trial and receive the combination on progression through the lead-in. 7. Documented prostate cancer progression as assessed by the investigator with RECIST v1.1 and PCWG3 criteria (Section 3.5) with at least two of the following criteria: 1. Progression of soft…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.