Actively Recruiting
Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer
Led by Institute of Cancer Research, United Kingdom · Updated on 2026-04-15
78
Participants Needed
4
Research Sites
231 weeks
Total Duration
On this page
Sponsors
I
Institute of Cancer Research, United Kingdom
Lead Sponsor
P
Prostate Cancer UK
Collaborating Sponsor
AI-Summary
What this Trial Is About
ASpiRE will investigate the effect of the drug SX-682 in combination with Apalutamide in men suffering from metastatic castration-resistant prostate cancer (mCRPC).
CONDITIONS
Official Title
Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and ability to cooperate with treatment
- Age 18 years or older
- Confirmed adenocarcinoma of the prostate with accessible tumor tissue for analysis
- For phase 1 cohorts, biopsiable disease with consent for pre- and post-treatment biopsies
- Diagnosis of metastatic castration-resistant prostate cancer
- Documented resistance to at least one prior next generation antiandrogen therapy (enzalutamide, Apalutamide, or darolutamide) with minimum 12 weeks treatment
- Documented prostate cancer progression by standard criteria including RECIST v1.1, PCWG3 bone scan, or PSA progression
- PSA level of 10 ng/ml or higher
- Prior castration by surgery or ongoing hormone therapy
- Ongoing androgen deprivation with serum testosterone below 50 ng/dL
- ECOG Performance Status of 2 or less
- Willingness to use effective contraception during and 6 months after treatment
- Ability to swallow study drug tablets
- Steroid use discontinued if possible; up to 5 mg twice daily prednisolone allowed
- Hematological and biochemical parameters within specified ranges measured within one week before starting trial
You will not qualify if you...
- Surgery, chemotherapy, or other anti-cancer therapy within 4 weeks before trial entry, except certain antiandrogen therapies
- Participation in another interventional clinical trial within 4 weeks prior
- Recent radiotherapy within 2 to 4 weeks before trial entry
- Clinical or biochemical hyperaldosteronism or hypopituitarism
- History of seizures or predisposing brain conditions
- Malabsorption syndrome or conditions affecting drug absorption
- Certain cardiac conditions including prolonged QTcF interval, arrhythmias, recent serious cardiac events, uncontrolled blood pressure
- Significant liver disease or cirrhosis
- Conditions contraindicating investigational drug use or causing high treatment risk
- Other malignancies within 5 years except treated basal cell carcinoma
- Unresolved significant toxicity from prior therapy
- Inability to comply with study procedures
- Predominantly small cell or neuroendocrine prostate cancer
- Immunocompromised status
- Active or uncontrolled autoimmune disease requiring corticosteroids
- Recent thromboembolic disease within 12 months
- Serious concurrent illness or infection
- Known intolerance to Apalutamide, SX-682, or components
- Symptoms or documented infection of COVID-19
- Use of prohibited medications including certain antipsychotics, antidepressants, anticoagulants, and others
- History of severe drug-induced skin reactions or pneumonitis requiring steroids
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH6500
Not Yet Recruiting
2
Belfast Health and Social Care Trust
Belfast, United Kingdom, BT9 7AB
Actively Recruiting
3
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Actively Recruiting
4
The Royal Marsden NHS Foundation Trust - Drug Development Unit
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
A
Aasia Hussain, PhD
CONTACT
B
Bindumalini Rao Baikady, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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