✅ This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
About This Trial
The study will be conducted in 4 parts and will commence with dose escalation of VIR-5500 as a monotherapy (Part 1), followed by combination escalation (Part 3a), monotherapy dose expansion (Part 2) and combination dose expansion (Part 4a).
* Part 1 (Monotherapy Dose Escalation): Single-agent VIR-5500 dose escalation
* Part 2 (Monotherapy Dose Expansion): Single-agent VIR-5500 dose expansion
* Part 3 (Combination Dose Escalation): VIR-5500 plus another therapeutic agent dose escalation Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI)
* Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion Part 4a (Combination Dose Expansion): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI)
Who Can Join?
Inclusion Criteria: Applicable to Parts 1 and 2 1. Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging 2. Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3) * PSA level ≥ 1 ng/mL that has increased on ≥ 2 successive occasions ≥ 1 week apart * Nodal or visceral progression as defined by RECIST v1.1 with PCWG3 modifications * Appearance of ≥ 2 new lesions in bone scan 3. Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and/or enzalutamide 4. Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel) 5. Are deemed unsuitable for standard of care Applicable to Part 2, 3a and Part 4a, 1. Have metastatic CRPC, defined by ≥ 1 metastatic lesion that is present on baseline CT,…
⚠ Always speak to your doctor before applying to any clinical trial.