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

Sponsor
Institute of Cancer Research, United Kingdom
Study ID
NCT07002320
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SX-682 — DRUG
    SX-682 is supplied as 100mg film coated tablets.
  • Apalutamide — DRUG
    Apalutamide is supplied as 60mg film coated tablets.

Study Details

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

Key Dates

Start date
Apr 28, 2025
Status verified
Apr 2026
Primary completion
Oct 31, 2029
Completion
Oct 31, 2029

Study Design

Enrollment
78 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Experimental: 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.

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) ]

Central Contacts

Related Studies

  • TmPSMA-02 in mCRPC
    PHASE1 · Recruiting · University of Pennsylvania · Philadelphia, Pennsylvania