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

PHASE1PHASE2RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 25 and older

Healthy volunteers accepted : No

Gender eligible for study: Female

Things to know

Study dates

Study start: 2024-03-27

Primary completion: 2025-05-31

Study completion finish: 2026-02-28

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT06491446

Intervention or treatment

DRUG: ABI-2280

Conditions

• Human Papillomavirus Infection

Image related to Human Papillomavirus Infection

Condition: Human Papillomavirus Infection
DRUG: ABI-2280
Adelaide, South Australia, Australia and more
Sponsor: Antiva Biosciences

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

PARC Clinical Research, Royal Adelaide Hospital

Research sites nearby

Select from list below to view details:

PARC Clinical Research, Royal Adelaide Hospital
Adelaide, South Australia, Australia
Emeritus Research Camberwell
Camberwell, Not Specified, Australia
Holdsworth House Medical Practice
Darlinghurst, Not Specified, Australia
KIMR
Nedlands, Not Specified, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts