Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts

Phase 1

Recruiting

• Conditions: Human Papillomavirus Infection
• Interventions: Drug: ABI-2280

• Registration Number: NCT06491446
• Lead Sponsor: Antiva Biosciences

Brief Summary

This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.

Detailed Description

This is a randomized, double-blind, placebo-controlled Phase 1b/2 study in women diagnosed with persistent cervical hrHPV infection. This study is designed to assess safety, tolerability, and efficacy following the use of ABI-2280 Vaginal Insert delivered intravaginally. Sentinel cohorts will be utilized to assess tolerable regimens, which may trigger cohort expansions if some evidence of efficacy is observed.

Dose range and dosing regimens in this study will be evaluated through the enrollment of up to 11 sentinel cohorts (including up to 5 optional cohorts), each enrolling up to 8 participants. The optional cohorts may be enrolled in the study at the Sponsor's discretion based on emerging data from this study and the ABI-2280 program, in case additional dose/regimen ranging or dosing method exploration is indicated. A sentinel cohort may be repeated to evaluate the dosing regimen using a different method of administration. Additionally, any cohort may be paused or terminated, as recommended by the Safety Monitoring Committee (SMC) and/or per the Sponsor's discretion based on the emerging data from the preceding cohort or from the ABI-2280 program. Such decisions will be based on safety and/or benefit-risk considerations.

Study Timeline

• Study Start: 2024-03-27
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-05-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Cohort 8	ABI-2280	Participants in this arm will receive either ABI 2280 (Dose 8) or matching placebo
Experimental: Cohort 9	ABI-2280	Participants in this arm will receive either ABI 2280 (Dose 9) or matching placebo
Experimental: Cohort 5	ABI-2280	Participants in this arm will receive either ABI 2280 (Dose 5) or matching placebo
Experimental: Cohort 6	ABI-2280	Participants in this arm will receive either ABI 2280 (Dose 6) or matching placebo
Experimental: Cohort 10	ABI-2280	Participants in this arm will receive either ABI 2280 (Dose 10) or matching placebo
Experimental: Cohort 1	ABI-2280	Participants in this arm will receive either ABI 2280 (Dose 1) or matching placebo
Experimental: Cohort 2	ABI-2280	Participants in this arm will receive either ABI 2280 (Dose 2) or matching placebo
Experimental: Cohort 3	ABI-2280	Participants in this arm will receive either ABI 2280 (Dose 3) or matching placebo
Experimental: Cohort 4	ABI-2280	Participants in this arm will receive either ABI 2280 (Dose 4) or matching placebo
Experimental: Cohort 7	ABI-2280	Participants in this arm will receive either ABI 2280 (Dose 7) or matching placebo
Experimental: Cohort 11	ABI-2280	Participants in this arm will receive either ABI 2280 (Dose 11) or matching placebo

Primary Outcome Measures

Name	Time	Method
For sentinel cohorts: Incidence and Severity of Adverse Events	Week 24	For sentinel cohorts: for each dose/dosing regimen, incidence and severity of adverse events (AEs), relationship of AEs to investigational product (IP), and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo
For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline	Week 12	Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders.

Secondary Outcome Measures

Name	Time	Method
For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events	Week 24	For fully expanded cohorts, including sentinel: for each dose/dosing regimen, incidence and severity of AEs, relationship of AEs to IP, and AEs leading to treatment reduction/discontinuation for ABI-2280 Vaginal Insert vs. pooled placebo.
Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders	Week 24	For fully expanded cohorts, including sentinel: For each dose/dosing regimen, proportion of participants who received ABI-2280 Vaginal Insert vs. pooled placebo who are complete responders, defined as the absence of all hrHPV genotypes that were present at baseline, at Week 24

Trial Locations

Locations (16)

Emeritus Research Camberwell; 🇦🇺 Camberwell, Australia

Holdsworth House Medical Practice; 🇦🇺 Darlinghurst, Australia

KIMR; 🇦🇺 Nedlands, Australia

The Royal Women's Hospital; 🇦🇺 Parkville, Australia

Emeritus Research Sydney; 🇦🇺 Sydney, Australia

AusTrials Taringa; 🇦🇺 Taringa, Australia

AusTrials Wellers Hill; 🇦🇺 Tarragindi, Australia

Waitemata Clinical Research Ltd; 🇳🇿 Birkenhead, New Zealand

P3 Research Dunedin; 🇳🇿 Dunedin, New Zealand

P3 Research Hawke's Bay; 🇳🇿 Hastings, New Zealand

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