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Zopapogene imadenovec-drba

Phase 3

Recurrent Respiratory Papillomatosis (RRP) | Gene therapy | Other |Precigen, Inc.|Trials Updated: Oct 28, 2026

Zopapogene imadenovec-drba development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since Oct 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Zopapogene imadenovec-drba clinical trials

Zopapogene imadenovec-drba · 1 trial · 3 indications

Phase 3 1
NCT07901738Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in ChildrenRecurrent Respiratory Papillomatosis (RRP)
NOT YET_RECRUITING15 Analytics
PHASE3NOT YET_RECRUITING
Zopapogene Imadenovec for the Treatment of Recurrent Respiratory Papillomatosis in Children
Recurrent Respiratory Papillomatosis (RRP)
NCT0790173815
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Study Endpoints

Primary Endpoints

Complete response rate
12 months following last administration of study drug

Percentage of participants with a complete response, defined as no requirement for any clinically indicated debulking intervention during the 12 months following the last administration of zopapogene imadenovec.

Secondary Endpoints

Number of participants with adverse events (AEs) and treatment-related AEs
From first administration through 12 months after the last administration (treatment-related AEs through 28 days after the last administration)
Time to first clinically indicated debulking intervention (duration of response)
From the last administration (Week 12) up to 5 years
Objective response rate (ORR)
12 months before the first administration and 12 months after the last administration
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Zopapogene imadenovecEXPERIMENTALParticipants receive four subcutaneous administrations of zopapogene imadenovec on Day 1, Week 2, Week 6, and Week 12, each in a different limb. Participants aged ≥6 to \<18 years receive 5 x 10\^11 particle units per injection; participants aged ≥1 to ≤5 years begin at 2.5 x 10\^11 particle units per injection with sentinel dosing. All participants undergo a standard-of-care debulking procedure on Day -1.

Interventions

NameTypeDescription
Zopapogene imadenovec-drbaBIOLOGICALZopapogene imadenovec
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Eligibility Criteria

Age Range1 Year to 17 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * Age 1 to 17 years * Clinical diagnosis of RRP with histologically confirmed papilloma * Laryngotracheal papillomas accessible for endoscopic debulking * At least 3 lifetime debulking procedures (the Day -1 procedure counts) * Active RRP, shown by at least 1 clinically indi...

Countries:United States
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Recent Changes (Last 90 Days)

LOWOct 28, 2026NCT07901738NEW_TRIAL: changed
LOWOct 28, 2026NCT07901738NEW_TRIAL: changed

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