- Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer — Recruiting • Phase I • Oncology • NCT05997615.
- VIR-5500 (AMX-500) is a novel therapeutic agent undergoing evaluation for safety, pharmacokinetics, and efficacy in prostate cancer, progressing from initial dose escalation as monotherapy through to combination therapy and expansion phases.
- Patient eligibility encompasses men with prostate cancer across escalation and expansion cohorts, with enrolment structured to establish tolerable doses and optimal treatment strategies in sequential study phases.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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 o Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI) (enzalutamide or darolutamide)…
- : Applicable to Parts 1 and 2 * Have metastatic disease, defined by ≥ 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging * Have documented progressive mCRPC based on ≥ 1 of the criteria (per PCWG3) * Have been treated with ≥ 1 second-generation androgen-signaling inhibitor, including abiraterone, apalutamide, darolutamide, and/or enzalutamide * Have been treated with ≥ 1 prior taxane regimens (e.g., docetaxel, cabazitaxel) * Are deemed unsuitable for standard of care Applicable to Part 2 Cohort 1 • Must have received standard-of-care radioligand-based therapies, including PSMA-targeted radiopharmaceutical therapy, such as 177Lu-PSMA-617 Applicable to Part 3a and Part 4a * Have metastatic CRPC, defined by ≥ 1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging that has documented progressive disease (PD) based on ≥ 1 of the following criteria (per PCWG3) * Have metastatic HSPC, defined by at least 1 and no more than 5 metastatic lesions with no visceral involvement that are present on baseline CT, MRI, or bone scan imaging * Have biochemical recurrent prostate cancer
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.