Search > Prostate Cancer
390 Participants NeededMy employer runs this trial

VIR-5500 for Prostate Cancer

Recruiting at 11 trial locations
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Overseen ByTrial Transparency email recommended (Toll free for US & Canada)
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Vir Biotechnology, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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

o Part 3a (Combination Dose Escalation): VIR-5500 in combination with an androgen receptor signaling inhibitor (ARSI) (enzalutamide or darolutamide)

* Part 4 (Combination Dose Expansion): VIR-5500 plus another therapeutic agent dose expansion o Part 4a (Combination Dose Expansion): VIR-5500 in combination with an ARSI (enzalutamide or darolutamide)

Who Is on the Research Team?

CS

Clinical Sciences & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

Inclusion Criteria

I have metastatic prostate cancer that has progressed after hormone and chemo treatments.
I have prostate cancer that has spread, or my PSA levels are rising after treatment.
I have received standard PSMA-targeted radioligand therapy for my cancer.

Exclusion Criteria

I have another medical or inflammatory condition that could increase my risk of side effects from VIR-5500.
I currently have an acute or chronic infection.
My tumors are close to important organs.
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • VIR-5500

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Part 4a: VIR-5500 in combination with an ARSI for Dose ExpansionExperimental Treatment2 Interventions
Group II: Part 3a: VIR-5500 in combination with an ARSI for Dose EscalationExperimental Treatment2 Interventions
Group III: Part 2: VIR-5500 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Group IV: Part 1: VIR-5500 Monotherapy Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vir Biotechnology, Inc.

Lead Sponsor

Trials
30
Recruited
13,300+

Amunix, a Sanofi Company

Lead Sponsor

Trials
2
Recruited
860+

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