Adjuvant PRGN-2012 in Adult Patients with Recurrent Respiratory Papillomatosis

Phase 1

Active, not recruiting

• Conditions: Papillomavirus Infections; Recurrent Respiratory Papillomatosis; Papillomaviridae
• Interventions: Drug: PRGN-2012

• Registration Number: NCT04724980
• Lead Sponsor: Precigen, Inc

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.

Study Timeline

• Study First Submitted: 2021-01-23
• Study First Submitted QC: 2021-01-23
• Study First Posted: 2021-01-26
• Study Start: 2021-03-16
• Primary Completion: 2024-06-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-06
• Last Update Posted: 2024-11-08
• Study Completion: 2026-06-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adjuvant PRGN-2012	PRGN-2012	Four PRGN-2012 administrations (on days 1, 15, 43, and 85) via subcutaneous injection.

Primary Outcome Measures

Name	Time	Method
Determine the incidence of dose limiting toxicities to evaluate safety and identify RP2D of PRGN-2012	28 days	The incidence of dose limiting toxicities in Phase 1 will be reported per dose level. The dose level at which less than or equal to 1 out of 6 patients experience DLT will be identified as a RP2D.
Determine the percentage of subjects with a complete response following treatment with PRGN-2012	1 year	A complete response is defined as no requirement for surgical intervention in the 12 months after treatment

Secondary Outcome Measures

Name	Time	Method
Number of surgery during the 12 months pre and 12 months post treatment	1 year	The number of surgeries in the 12 months post-treatment will be compared to the number of surgeries in the 12 months pre-treatment.
Overall Response Rate	1 year	Determine the percentage of subjects with at least a 50% decrease in the number of surgeries during the 12 month period following completion of PRGN-2012 treatment as compared to the number of surgeries during the 12 months prior to PRGN-2012 treatment initiation.
Immune Responses	1 year	Change in HPV-specific T cells post-treatment compared to baseline
Change in Vocal Function Scores over Time	1 year	Absolute and percentage change from baseline in VHI-10 score over time following initiation of PRGN-2012 treatment
Change in RRP Staging Assessment Scores Over Time	1 year	Absolute and percentage change from baseline in Derkay score over time following initiation of PRGN-2012 treatment
Time to recurrence of papillomatous disease after completion of treatment	1 year	Time to recurrence of papillomatous disease after completion of treatment will be recorded. Time from completion of treatment to first surgery will be assessed.
Percentage of subjects with reduction in number of surgeries after completion of treatment	1 year	The number of surgeries in the 12 months post-treatment will be compared to the number of surgeries in the 12 months pre-treatment to identify subjects that have a reduction in the number of surgeries.
Safety of PRGN 2012 at RP2D	1 year	Systemic toxicity will be assessed through the capture of Treatment Emergent Adverse Events ( TEAEs) at Phase 1 and Phase 2 patients. The severity of the TEAEs will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0 scale.
Rate of pulmonary RRP complete response in participants with pulmonary disease	1 year	The fraction of participants with a pulmonary RRP complete response will be reported in all treated pulmonary participants.
Rate of pulmonary RRP partial response in participants with pulmonary disease	1 year	The fraction of participants with a pulmonary RRP partial response will be reported in all treated pulmonary participants.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States