Confirmatory Study of PRGN-2012 in Patients with RRP

Precigen

Status and phase

Enrolling

Phase 3

Conditions

Recurrent Respiratory Papillomatosis

Papillomaviridae

Papillomavirus Infection

Treatments

Drug: PRGN-2012

Study type

Interventional

Funder types

Industry

Identifiers

NCT06538480

PRGN-2012-301

Details and patient eligibility

About

The purpose of this confirmatory study is to provide further demonstration of the efficacy of PRGN-2012 for the treatment of RRP in adults.

Full description

This is a single-arm, open-label confirmatory study of PRGN-2012 in RRP patients with a history of repeated surgical debulking for the management of their disease. Patients will be treated with PRGN-2012 and followed for at least 12 months to evaluate for efficacy and safety endpoints.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Age 18 years and older
Clinical diagnosis of RRP requiring surgical intervention
Performance status of ECOG of 0-1
Sexually active participants (men and women) of reproductive potential must agree to use contraception.
All participants must have the ability to understand and willingness to sign a written informed consent

Key Exclusion Criteria:

Severe acute or chronic medical or psychiatric conditions that, in the opinion of the investigators, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results and in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Participants receiving any prohibited medications including immunosuppressive medications and other treatments for RRP.
Participants who had received any other investigational agents within the past 30 days.
Pregnant women are excluded from this study