Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer
NCT ID: NCT07002320
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
78 participants
INTERVENTIONAL
2025-04-28
2029-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase I: Dose Escalation
Phase I will identify a biologically active and tolerable (safe) dose range of SX-682 in combination with Apalutamide in patients with metastatic castrate-resistant prostate cancer (mCRPC).
SX-682
SX-682 is supplied as 100mg film coated tablets.
Apalutamide
Apalutamide is supplied as 60mg film coated tablets.
Phase II: Dose Expansion
Phase I will investigate the anti-tumour activity of tolerable doses of SX-682 in combination with Apalutamide in patients with metastatic castrate-resistant prostate cancer (mCRPC). Patients will be treated at dose levels deemed to be tolerable and biologically active, based on safety and efficacy data from Dose Escalation.
SX-682
SX-682 is supplied as 100mg film coated tablets.
Apalutamide
Apalutamide is supplied as 60mg film coated tablets.
Interventions
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SX-682
SX-682 is supplied as 100mg film coated tablets.
Apalutamide
Apalutamide is supplied as 60mg film coated tablets.
Eligibility Criteria
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Inclusion Criteria
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 tissue/visceral disease by RECIST v1.1 and/or,
2. Progression of bone disease by PCWG3 bone scan criteria and/or,
3. Progression of PSA by PCWG3 PSA criteria.
8. PSA ≥ 10ng/ml.
9. Received prior castration by orchiectomy and/or ongoing luteinizing hormone releasing hormone agonist treatment.
10. Ongoing androgen deprivation with serum testosterone \< 50 ng/dL (\< 1.7 nM).
11. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
12. Documented willingness to use an effective means of contraception while participating in the study and for 6 months post last treatment dose.
13. Able to swallow the study drug.
14. All efforts should be made to discontinue steroid usage but up-to 5mg BD prednisolone (or equivalent) will be allowed.
15. Haematological and biochemical indices within the ranges shown below. These measurements must be performed within one week (Day -7 to Day 1) before the patient goes on trial.
Haemoglobin (Hb) ≥ 9.0 g/dL Absolute neutrophil count ≥ 1.5 x 109/L Platelet count ≥ 100 x 109/L WBC ≥ 3.0 x 109/L Calculated creatinine clearance ≥ 50 mL/min (uncorrected value) Serum bilirubin ≤ 1.5 x upper limit of normal (ULN) unless documented Gilbert's disease., in which case ≤ 3 x ULN is permissible Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x (ULN) unless raised due to known metastatic liver disease in which case ≤ 5 x ULN is permissible
Exclusion Criteria
2. 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.
3. Prior limited field radiotherapy within 2 weeks and wide field radiotherapy within 4 weeks prior to trial entry.
4. Clinical and/or biochemical evidence of hyperaldosteronism or hypopituitarism.
5. History of seizures or other predisposing factors including, but not limited to, underlying brain injury, stroke, primary brain tumours, brain metastases and leptomeningeal disease, or alcoholism.
6. Malabsorption syndrome or other condition that would interfere with enteral absorption.
7. Any of the following cardiac criteria:
* QTcF interval \> 470 msec.
* Clinically important abnormalities including rhythm, conduction, or electrocardiogram (ECG) changes (left bundle branch block, third degree heart block).
* Factors predisposing to QT prolongation including heart failure, hypokalaemia, congenital long QT syndrome, family history of prolonged QT syndrome, unexplained sudden death (under 40) and concomitant medications known to prolong QT interval.
* Coronary artery bypass, angioplasty, vascular stent, myocardial infarction, angina, congestive heart failure (NYHA ≥ grade 2) i or transient ischaemic attack) in the last 6 months (see appendix 4 for NYHA scale).
* Uncontrolled hypotension (systolic blood pressure \< 90mmHg).
* Uncontrolled hypertension on optimal medical management.
8. Clinically significant history of liver disease (Child-Pugh B or C, viral or other hepatitis, current alcohol abuse or cirrhosis).
9. Any other finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect interpretation of the results or renders the patients at high risk from treatment complications, e.g., patients with a hypersensitivity to the active substance or any of the excipients.
10. Malignancy other than prostate cancer within 5 years of trial entry except for adequately treated basal cell carcinoma.
11. Unresolved significant toxicity from prior therapy (except alopecia and grade 1 peripheral neuropathy).
12. Inability to comply with study and follow-up procedures.
13. Predominantly small cell or neuroendocrine differentiated (\> 20% of cells) prostate cancer.
14. Immunocompromised patients.
15. Active or uncontrolled autoimmune disease requiring corticosteroid therapy.
16. History of thromboembolic disease within 12 months of commencement of trial.
17. At high-risk because of non-malignant systemic disease including active infection and any serious concurrent illness.
18. Any known intolerance to Apalutamide, SX-682, or to any constituents.
19. Symptoms of COVID-19 and/or documented COVID-19 infection.
20. Is taking any of the following prohibited medications:
* Aminophylline/theophylline
* Atypical antipsychotics (eg, clozapine, olanzapine, risperidone, ziprasidone)
* Buproprion
* Lithium
* Meperidine and pethidine
* Phenothiazine antipsychotics (eg, chlorpromazine, mesoridazine, thioridazine)
* Tricyclic and tetracyclic antidepressants (eg, amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine
* Warfarin or coumarin-like anticoagulants
21. History of previous non-infectious pneumonitis requiring steroid treatment, or active non-infectious pneumonitis.
22. History of previous severe drug induced severe cutaneous reaction including but not limited to Steven-Johnson's syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS).
18 Years
MALE
No
Sponsors
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Prostate Cancer UK
OTHER
Janssen Pharmaceutica N.V., Belgium
INDUSTRY
Oncology Institute of Southern Switzerland
OTHER
Syntrix Biosystems, Inc.
INDUSTRY
Royal Marsden NHS Foundation Trust
OTHER
Cambridge University Hospitals NHS Foundation Trust
OTHER
Belfast Health and Social Care Trust
OTHER
Institute of Oncology Research (IOR)
UNKNOWN
Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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Professor Johann de Bono, MB ChB, FRCP, MSc, PhD, FMedSc
Role: STUDY_DIRECTOR
Institute of Cancer Research, United Kingdom
Locations
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Oncology Institute of Southern Switzerland
Bellinzona, , Switzerland
Belfast Health and Social Care Trust
Belfast, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, , United Kingdom
The Royal Marsden NHS Foundation Trust - Drug Development Unit
Sutton, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Professor Dr. Med. Andrea Alimonti, Translational Scientific Lead Coordinator at the IOR
Role: backup
Other Identifiers
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1008729
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCR6041
Identifier Type: -
Identifier Source: org_study_id
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