Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer

Conditions

• Hormone-refractory Prostate Cancer

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• VIR-5500 — DRUG
  Pharmaceutical form: Solution for infusion Route of administration: Intravenous (IV) infusion
• ARSI — COMBINATION_PRODUCT
  Oral administration

Study Details

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)

Key Dates

Start date

Aug 10, 2023

Status verified

May 2026

Primary completion

Sep 29, 2027

Completion

Sep 29, 2027

Study Design

Enrollment

437 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part 1: VIR-5500 Monotherapy Dose Escalation
  VIR-5500 will be administered as a monotherapy in patients with mCRPC over a 21-day or 28-day cycle
• Experimental: Part 2: VIR-5500 Monotherapy Dose Expansion
  VIR-5500 will be administered as a monotherapy in patients with mCRPC over a 21-day or 28-day cycle
• Experimental: Part 3a: VIR-5500 in combination with an ARSI for Dose Escalation
  VIR-5500 will be administered in combination with ARSI over a 21-day or 28-day cycle
• Experimental: Part 4a: VIR-5500 in combination with an ARSI for Dose Expansion
  VIR-5500 will be administered in combination with ARSI over a 21-day or 28-day cycle

Primary Outcome Measure

Part 1 and 3a: Number of participants with treatment-emergent Adverse Events (AEs) [ Time Frame: from the Cycle 1(each cycle is 21 or 28 days), Day 1 up to approximately 48 months ]

Central Contacts

• Study Inquiry
  415-654-5281
  [email protected]

Locations (4)

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