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OncoMatch/Clinical Trials/NCT07002320

Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer

Is NCT07002320 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including SX-682 and Apalutamide for metastatic castrate-resistant prostate cancer (mcrpc).

Phase 1/2RecruitingInstitute of Cancer Research, United KingdomNCT07002320Data as of May 2026

Treatment: SX-682 · ApalutamideASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC).

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Extracted eligibility criteria

Cancer type

Prostate Cancer

Disease stage

Required: Stage IV

Metastatic disease required

Metastatic castration-resistant prostate cancer

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: antiandrogen (enzalutamide, apalutamide, darolutamide) — next generation antiandrogen therapy (NAAT)

documented resistance to 1 prior next generation antiandrogen therapy (NAAT) defined as: Patients who have progressed after either enzalutamide, Apalutamide or darolutamide (having received a minimum of 12-weeks of enzalutamide, Apalutamide or darolutamide)

Cannot have received: surgery, chemotherapy, or other anti-cancer therapy

Exception: abiraterone, enzalutamide, apalutamide, darolutamide, and gonadotropin releasing hormone analogue therapy allowed

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.

Cannot have received: radiation therapy

Prior limited field radiotherapy within 2 weeks and wide field radiotherapy within 4 weeks prior to trial entry

Lab requirements

Blood counts

Haemoglobin (Hb) ≥ 9.0 g/dL; Absolute neutrophil count ≥ 1.5 x 10^9/L; Platelet count ≥ 100 x 10^9/L; WBC ≥ 3.0 x 10^9/L

Kidney function

Calculated creatinine clearance ≥ 50 mL/min (uncorrected value)

Liver function

Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) unless documented Gilbert's disease, in which case ≤ 3 x ULN is permissible; ALT and AST ≤ 2.5 x ULN unless raised due to known metastatic liver disease in which case ≤ 5 x ULN is permissible

Cardiac function

QTcF interval > 470 msec, clinically important abnormalities including rhythm, conduction, or ECG changes (left bundle branch block, third degree heart block), factors predisposing to QT prolongation, coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina, congestive heart failure (NYHA ≥ grade 2) or transient ischaemic attack in the last 6 months, uncontrolled hypotension (systolic blood pressure < 90mmHg), uncontrolled hypertension on optimal medical management

Haematological and biochemical indices within the ranges shown below...QTcF interval > 470 msec...coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina, congestive heart failure (NYHA ≥ grade 2) or transient ischaemic attack in the last 6 months...uncontrolled hypotension...uncontrolled hypertension

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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