Metastatic Castrate-Resistant Prostate Cancer (mCRPC)Phase 1/2ASpiRENCT07002320
Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer
A Phase 1/2 study testing SX-682 and Apalutamide in people with Metastatic Castrate-Resistant Prostate Cancer (mCRPC), run by Institute of Cancer Research, United Kingdom at 4 sites in 2 countries.
Trial summary
ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
- What is being tested?
- SX-682 and Apalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 28 Apr 2025to Oct 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 biopsy to prove prostate adenocarcinoma.
- 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:
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- 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.
- 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 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
Who cannot join
- 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.
- 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.
- 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.
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- 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.
- 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 treatment complications, e.g., patients with a hypersensitivity to the active substance or any of the excipients.
- 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).
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United Kingdom3 sites, 3 recruiting
- Recruiting
Belfast Health and Social Care Trust
Belfast, BT9 7AB
Dr Vicky Coyle, 02895048492, v.coyle@qub.ac.uk
Dr Vicky Coyle
- Recruiting
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ
Dr Simon Pacey, 07712201563, scp46@medschl.cam.ac.uk
Dr Simon Pacey
- Recruiting
The Royal Marsden NHS Foundation Trust - Drug Development Unit
Sutton, SM2 5PT
Professor Johann de Bono, 02087224028, Johann.DeBono@icr.ac.uk
Professor Johann de Bono
Switzerland1 site, 1 recruiting
- Recruiting
Oncology Institute of Southern Switzerland
Bellinzona, CH6500
Dr Ursula Vogl, 091 811 84 63, Ursula.Vogl@eoc.ch
Professor Dr. Med. Andrea Alimonti, Translational Scientific Lead Coordinator at the IOR, andrea.alimonti@ior.usi.ch
About this study
Official title: 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)
ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC).
- Being tested
- SX-682, Apalutamide
- Keywords
- Prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SX-682Drug
SX-682 is supplied as 100mg film coated tablets.
ApalutamideDrug
Apalutamide is supplied as 60mg film coated tablets.
| Study group | Role | What they receive |
|---|---|---|
| Phase I: Dose Escalation | Experimental | 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). Receives: Drug: SX-682; Drug: Apalutamide |
| Phase II: Dose Expansion | Experimental | 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. Receives: Drug: SX-682; Drug: Apalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biologically active and tolerable dose range
The biological active and tolerable combination doses are those that satisfy observed DLT rate<33% and demonstrate reduction in myeloid derived suppressor cells (MDSCs).
Measured: 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
Response rate on the basis of Prostate Cancer Working Group 3 (PCWG3), and/or Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
Measured: 24 months
Secondary outcomes (11)
Safety and tolerability profile as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 12 months
Steady state pharmacokinetic parameters (CSSmin and CSSMax)
Measured: At the end of Cycle 2 Day 1 (each cycle is 28 days).
Number of patients with Prostate Specific Antigen (PSA) decline greater than 50%
Measured: 24 months
Soft tissue objective response (CR or PR) by RECIST v1.1
Measured: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Changes in circulating tumour DNA (ctDNA) tumour fractions (TF).
Measured: 24 months
Progression free survival
Measured: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival
Measured: From date of enrolment to date of death from any cause, assessed up to 60 months.
Relative changes in circulating neutrophils
Measured: 24 months
Impact on quality of life using Brief Pain Inventory (BPI) Questionnaire
The BPI questionnaire assesses pain severity and impact of pain on daily functioning. Higher scores indicate greater pain severity and interference with daily life.
Measured: 24 months
Impact of treatment toxicity using Functional Assessment of Chronic Illness Therapy (FACIT)-GP5 Questionnaire
Score between 0-4 with high score meaning patients are bothered by treatment side effects
Measured: 24 months
Relative changes in intra-tumour myeloid derived suppressor cells (MDSCs)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start28 Apr 2025
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castrate-Resistant Prostate Cancer (mCRPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 will use a 3+3 design to investigate escalating doses of SX-682 in combination with Apalutamide.
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer UK, Janssen Pharmaceutica N.V., Belgium, Oncology Institute of Southern Switzerland, Syntrix Biosystems, Inc., Royal Marsden NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Belfast Health and Social Care Trust, Institute of Oncology Research (IOR)
- Responsible party
- Sponsor
- Investigators
- Professor Johann de Bono, MB ChB, FRCP, MSc, PhD, FMedSc, Study director, Institute of Cancer Research, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002320
- Sponsor's protocol ID
- CCR6041
- Other IDs
- 1008729
- Acronym
- ASpiRE
- Status last verified
- Sep 2026
- First submitted
- 6 May 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07002320
- Acronym / sponsor ID
- ASpiRE / CCR6041
- Keywords
- Prostate cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Prostate Cancer UK, Janssen Pharmaceutica N.V., Belgium, Oncology Institute of Southern Switzerland, Syntrix Biosystems, Inc., Royal Marsden NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Belfast Health and Social Care Trust, Institute of Oncology Research (IOR)
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 will use a 3+3 design to investigate escalating doses of SX-682 in combination with Apalutamide.
| Arm | Type | Receives |
|---|---|---|
| Phase I: Dose Escalation | Experimental | Drug: SX-682, Drug: ApalutamidePhase 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). |
| Phase II: Dose Expansion | Experimental | Drug: SX-682, Drug: ApalutamidePhase 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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 biopsy to prove prostate adenocarcinoma.
- 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.
Key exclusion criteria (36 listed)
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SX-682SX-682 is supplied as 100mg film coated tablets. | Drug | Phase I: Dose Escalation, Phase II: Dose Expansion |
| ApalutamideApalutamide is supplied as 60mg film coated tablets. | Drug | Phase I: Dose Escalation, Phase II: Dose Expansion |
Primary outcome
Biologically active and tolerable dose range
Time frame: From start of treatment to end of Cycle 2 Day 1 (each cycle is 28 days)
The biological active and tolerable combination doses are those that satisfy observed DLT rate<33% and demonstrate reduction in myeloid derived suppressor cells (MDSCs).
Anti-tumour activity of SX-682 when administered with Apalutamide
Time frame: 24 months
Response rate on the basis of Prostate Cancer Working Group 3 (PCWG3), and/or Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria.
11 secondary outcomes
Safety and tolerability profile as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: 12 months
Steady state pharmacokinetic parameters (CSSmin and CSSMax)
Time frame: At the end of Cycle 2 Day 1 (each cycle is 28 days).
Number of patients with Prostate Specific Antigen (PSA) decline greater than 50%
Time frame: 24 months
Soft tissue objective response (CR or PR) by RECIST v1.1
Time frame: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Changes in circulating tumour DNA (ctDNA) tumour fractions (TF).
Time frame: 24 months
Progression free survival
Time frame: From date of enrolment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Overall survival
Time frame: From date of enrolment to date of death from any cause, assessed up to 60 months.
Relative changes in circulating neutrophils
Time frame: 24 months
Impact on quality of life using Brief Pain Inventory (BPI) Questionnaire
Time frame: 24 months
Impact of treatment toxicity using Functional Assessment of Chronic Illness Therapy (FACIT)-GP5 Questionnaire
Time frame: 24 months
Relative changes in intra-tumour myeloid derived suppressor cells (MDSCs)
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Professor Johann de Bono, MB ChB, FRCP, MSc, PhD, FMedSc study director
Institute of Cancer Research, United Kingdom
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SX-682 and Apalutamide in people with Metastatic Castrate-Resistant Prostate Cancer (mCRPC), run by Institute of Cancer Research, United Kingdom at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aasia Hussain, PhD (02034376301, ASPIRE@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biologically active and tolerable dose range (time frame: From start of treatment to end of Cycle 2 Day 1 (each cycle is 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.