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New treatment option for Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Official title Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer
ClinicalTrials.gov ID: NCT07002320
What this study is testing
What is SX-682?
SX-682 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic castrate-resistant prostate cancer (mcrpc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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 recruited to phase 1 dose escalation cohorts must have biopsiable disease and consent to mandatory pre- and post-treatment biopsies...
- Metastatic castration-resistant prostate cancer.
You likely can't join if
- Surgery, chemotherapy, or other anti-cancer therapy within 4 weeks prior to trial entry/randomisation into the study (with the exception of...
- Participation in another treatment clinical trial of an IMP within 4 weeks prior to trial entry. Participation in trials of licensed medications is...
- 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.
- History of seizures or other predisposing factors including, but not limited to, underlying brain injury, stroke, primary brain tumours, brain...
- Malabsorption syndrome or other condition that would interfere with enteral absorption.
See the full eligibility criteria
Who can join
- 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...
- 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).
- Metastatic castration-resistant prostate cancer.
- 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...
- 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:
- Progression of soft tissue/visceral disease by RECIST v1.1 and/or,
- Progression of bone disease by PCWG3 bone scan criteria and/or,
- Progression of PSA by PCWG3 PSA criteria.
- PSA ≥ 10ng/ml.
- Received prior castration by orchiectomy and/or ongoing luteinizing hormone releasing hormone agonist treatment.
- Ongoing androgen deprivation with serum testosterone \< 50 ng/dL (\< 1.7 nM).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2.
- Documented willingness to use an effective means of contraception while participating in the study and for 6 months post last treatment dose.
- Able to swallow the study drug.
- All efforts should be made to discontinue steroid usage but up-to 5mg BD prednisolone (or equivalent) will be allowed.
- 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...
What rules you out
- 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...
- Participation in another treatment 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...
- 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.
- 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.
- Malabsorption syndrome or other condition that would interfere with enteral absorption.
- 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...
- 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.
- Clinically significant history of liver disease (Child-Pugh B or C, viral or other hepatitis, current alcohol abuse or cirrhosis).
- 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...
- Malignancy other than prostate cancer within 5 years of trial entry except for adequately treated basal cell carcinoma.
- Unresolved significant toxicity from prior therapy (except alopecia and grade 1 peripheral neuropathy).
- Inability to comply with study and follow-up procedures.
- Predominantly small cell or neuroendocrine differentiated (\> 20% of cells) prostate cancer.
- Immunocompromised patients.
- Active or uncontrolled autoimmune disease requiring corticosteroid therapy.
- History of thromboembolic disease within 12 months of commencement of trial.
- At high-risk because of non-malignant systemic disease including active infection and any serious concurrent illness.
- Any known intolerance to Apalutamide, SX-682, or to any constituents.
- Symptoms of COVID-19 and/or documented COVID-19 infection.
- 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
- History of previous non-infectious pneumonitis requiring steroid treatment, or active non-infectious pneumonitis.
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Bellinzona, Switzerland
- Belfast, United Kingdom
- Cambridge, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bellinzona, Switzerland; Belfast, United Kingdom; Cambridge, United Kingdom; Sutton, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.