Spots Global Cancer Trial Database for Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

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Trial Identification

Brief Title: Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

Official Title: A Phase 1/2 Study of Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

Study ID: NCT04724980

Conditions

Recurrent Respiratory Papillomatosis

Papillomavirus Infections

Papillomaviridae

Interventions

PRGN-2012

Study Description

Brief Summary: This is a Phase 1/2 study in patients with a Recurrent Respiratory Papillomatosis (RRP) disease burden that requires repeated surgical procedures for management. RRP is a rare disease caused by the human papillomavirus (HPV). Participants with a pathologically confirmed diagnosis of papilloma and a clinical diagnosis of RRP will be screened for this protocol.

Detailed Description: This is a nonrandomized, Phase 1/2 safety and tolerability study. The safety and tolerability of PRGN-2012 will be assessed following two different dose levels during the Phase 1 dose escalation trial. In the Phase 2 portion of the study, treatment with PRGN-2012 at the recommended Phase 2 dose (RP2D) will be used to determine safety and efficacy of PRGN-2012.