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

A Randomized, Placebo-Controlled Study to Evaluate Clearance of High-Risk Human Papillomavirus and Safety After Administration of ABI-2280 Vaginal Inserts

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Human Papillomavirus Infection
• Intervention / Treatment: Drug: ABI-2280

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, each enrolling up to 8 participants.

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Camberwell, Australia
    • Emeritus Research Camberwell
  • Darlinghurst, Australia
    • Holdsworth House Medical Practice
  • Nedlands, Australia
    • KIMR
  • Parkville, Australia
    • The Royal Women's Hospital
  • Sydney, Australia
    • Emeritus Research Sydney
  • Taringa, Australia
    • AusTrials Taringa
  • Tarragindi, Australia
    • AusTrials Wellers Hill
  • South Australia
    • Adelaide, South Australia, Australia
      • PARC Clinical Research, Royal Adelaide Hospital
• Kenya
  • Eldoret, Kenya, 8088-30100
    • International Cancer Institute
  • Kisii, Kenya, 1376-40500
    • Victoria Cancer Care & Research Centres
  • Kisumu, Kenya, 614-40100
    • Kenya Medical Research Institute (KEMRI) - RCTP Kisumu
  • Kisumu, Kenya, 7180-40100
    • Victoria Biomedical Research Institute
• Mexico
  • Cuauhtémoc, Mexico, CP 06700
    • ARKE Estudios Clínicos S.A. de C.V.
  • Mexico City, Mexico, CP 04700
    • Centro Oncológico Internacional
  • Querétaro, Mexico, CP 76800
    • Unidad de Medicina Especializada SMA
  • Veracruz, Mexico, CP 91900
    • FAICIC S. de R.L. de C.V.
• New Zealand
  • Birkenhead, New Zealand
    • Waitemata Clinical Research Ltd
  • Dunedin, New Zealand
    • P3 Research Dunedin
  • Hastings, New Zealand
    • P3 Research Hawke's Bay
  • Lower Hutt, New Zealand
    • P3 Research Lower Hutt
  • Nelson, New Zealand
    • Pacific Clinical Trials Network - Tasman
  • Paraparaumu, New Zealand
    • P3 Research Kapiti
  • Rotorua, New Zealand
    • Lakeland Clinical Trials
  • Tauranga, New Zealand
    • Clinical Horizons New Zealand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Female sex, 25 to 55 years of age
• Positive hrHPV result on at least 2 consecutive tests prior to randomization, one hrHPV+ result at least 12 months prior to screening
• Cervical cytology, colposcopy and/or biopsy performed within the last 6 months confirming disease status no greater than low-grade squamous intraepithelial lesions or cervical intraepithelial neoplasia grade 1.

Exclusion Criteria

• History of biopsy or colposcopy indicating high-grade squamous intraepithelial lesions, or history of endocervical curettage positive for glandular dysplasia
• Any clinically significant immune suppressing condition
• History or current diagnosis of cervical cancer, suspected or confirmed
• Plan to have excision or ablation of cervical or vaginal lesions, or to undergo large loop excision of the transformation zone at any time during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

11

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Experimental: Cohort 1; Participants in this arm will receive either ABI 2280 (Dose 1) or matching placebo	Drug: ABI-2280; Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Active Comparator: Experimental: Cohort 2; Participants in this arm will receive either ABI 2280 (Dose 2) or matching placebo	Drug: ABI-2280; Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Active Comparator: Experimental: Cohort 3; Participants in this arm will receive either ABI 2280 (Dose 3) or matching placebo	Drug: ABI-2280; Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Active Comparator: Experimental: Cohort 4; Participants in this arm will receive either ABI 2280 (Dose 4) or matching placebo	Drug: ABI-2280; Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Active Comparator: Experimental: Cohort 5; Participants in this arm will receive either ABI 2280 (Dose 5) or matching placebo	Drug: ABI-2280; Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Active Comparator: Experimental: Cohort 6; Participants in this arm will receive either ABI 2280 (Dose 6) or matching placebo	Drug: ABI-2280; Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Active Comparator: Experimental: Cohort 7; Participants in this arm will receive either ABI 2280 (Dose 7) or matching placebo	Drug: ABI-2280; Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Active Comparator: Experimental: Cohort 8; Participants in this arm will receive either ABI 2280 (Dose 8) or matching placebo	Drug: ABI-2280; Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Active Comparator: Experimental: Cohort 9; Participants in this arm will receive either ABI 2280 (Dose 9) or matching placebo	Drug: ABI-2280; Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Active Comparator: Experimental: Cohort 10; Participants in this arm will receive either ABI 2280 (Dose 10) or matching placebo	Drug: ABI-2280; Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.
Active Comparator: Experimental: Cohort 11; Participants in this arm will receive either ABI 2280 (Dose 11) or matching placebo	Drug: ABI-2280; Different strength of ABI 2280 will be administered in different cohorts. Other: Placebo Matching placebo will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
For sentinel cohorts: Incidence and Severity of Adverse Events	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	Week 24
For fully expanded cohorts, including sentinel: Clearance of persistent cervical hrHPV infection as defined by the absence of all hrHPV genotypes present at baseline	Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
For fully expanded cohorts, including sentinel: Incidence and Severity of Adverse Events	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.	Week 24
Proportion of participants who received ABI-2280 vs pooled placebo who are complete responders	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	Week 24

Collaborators and Investigators

• Sponsor: Antiva Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2024
• Primary Completion (Actual): October 16, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: HPV; CIN; sexually-transmitted infection; high-risk HPV
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; DNA Virus Infections; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Sexually Transmitted Diseases; Papillomavirus Infections
• Other Study ID Numbers: ABI-2280-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes