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

Antiva Biosciences

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Human Papillomavirus Infection

Treatments: Drug: ABI-2280

Study type: Interventional

Funder types: Industry

Identifiers

NCT06491446

ABI-2280-401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 11 patient groups

Experimental: Cohort 1

Active Comparator group

Description:

Participants in this arm will receive either ABI 2280 (Dose 1) or matching placebo

Treatment:

Drug: ABI-2280

Experimental: Cohort 2

Active Comparator group

Description:

Participants in this arm will receive either ABI 2280 (Dose 2) or matching placebo

Treatment:

Drug: ABI-2280

Experimental: Cohort 3

Active Comparator group

Description:

Participants in this arm will receive either ABI 2280 (Dose 3) or matching placebo

Treatment:

Drug: ABI-2280

Experimental: Cohort 4

Active Comparator group

Description:

Participants in this arm will receive either ABI 2280 (Dose 4) or matching placebo

Treatment:

Drug: ABI-2280

Experimental: Cohort 5

Active Comparator group

Description:

Participants in this arm will receive either ABI 2280 (Dose 5) or matching placebo

Treatment:

Drug: ABI-2280

Experimental: Cohort 6

Active Comparator group

Description:

Participants in this arm will receive either ABI 2280 (Dose 6) or matching placebo

Treatment:

Drug: ABI-2280

Experimental: Cohort 7

Active Comparator group

Description:

Participants in this arm will receive either ABI 2280 (Dose 7) or matching placebo

Treatment:

Drug: ABI-2280

Experimental: Cohort 8

Active Comparator group

Description:

Participants in this arm will receive either ABI 2280 (Dose 8) or matching placebo

Treatment:

Drug: ABI-2280

Experimental: Cohort 9

Active Comparator group

Description:

Participants in this arm will receive either ABI 2280 (Dose 9) or matching placebo

Treatment:

Drug: ABI-2280

Experimental: Cohort 10

Active Comparator group

Description:

Participants in this arm will receive either ABI 2280 (Dose 10) or matching placebo

Treatment:

Drug: ABI-2280

Experimental: Cohort 11

Active Comparator group

Description:

Participants in this arm will receive either ABI 2280 (Dose 11) or matching placebo

Treatment:

Drug: ABI-2280