A Study of ABI-2280 Vaginal Insert (Previously Referred to as ABI-2280 Vaginal Tablet) in Participants With Cervical Intraepithelial Neoplasia

An Open-Label Single and Multiple-dose, Study to Evaluate Safety, Tolerability and Efficacy of ABI-2280 Vaginal Insert (Previously Referred to as ABI-2280 Vaginal Tablet) in Participants With Cervical Squamous Intraepithelial Lesions

This is an open-label study to evaluate the safety, tolerability, and efficacy of ABI-2280 in participants with cervical squamous intraepithelial lesions. This study is divided into 2 parts - Part A and Part B.

Part A consists of up to 9 dose escalation cohorts. Part B consists of dose expansion cohorts.

Participants will self-administer ABI-2280.

Study Overview

• Status: Terminated
• Conditions: Cervical Intraepithelial Neoplasia
• Intervention / Treatment: Drug: ABI-2280 Vaginal Tablet/Insert

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • East Sydney Doctors
• Peru
  • Cusco, Peru
    • CerviCusco
  • Lima, Peru
    • Ginobs S.A.
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • FARMOVS
  • Gauteng
    • Sunnyside, Gauteng, South Africa, 0002
      • Nafasi Integrated Solutions
    • Waltloo, Gauteng, South Africa, 0184
      • Botho ke Bontle Health Services
  • Limpopo
    • Ga-Mothapo, Limpopo, South Africa
      • Gole Biomedical Research Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women, 25 to 55 years old.
• For Cohorts A1 and A2 in Part A, participants with biopsy-confirmed CIN (with visible lesions) regardless of p16 positivity may be enrolled upon consultation with PI and Medical Monitor. These participants will not be required to get LLETZ if not medically necessary, as determined by the PI in consultation with the Medical Monitor.
• For Cohorts A3 and above in Part A and Part B POC cohorts, biopsy-confirmed cHSIL that is p16+ (p16INK4a expressed) within 60 days of enrollment (dosing) with no evidence of invasive cancer in any specimen. If biopsy was performed ≥ 60 days before planned enrollment, participants must agree to have another biopsy performed at the Screening visit, unless approved by the Medical Monitor.
• A positive high-risk HPV (hrHPV) result by provider-obtained cervical swab at screening or previously obtained and documented within the past 3 months.
• No prior treatment for Cervical intraepithelial neoplasia (CIN).
• Generally, in good health with no clinically significant pulmonary, cardiac, gastro-enterologic, neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or endocrine disease.

Exclusion Criteria:

• Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
• Unwilling to use stringent methods of contraception (including barrier method, as well as another acceptable method) throughout the course of the study.
• History of cancer, except basal cell or squamous cell carcinoma of the skin.
• History of genital herpes with outbreak within prior 12 months.
• Have an active pelvic or non-HPV (Human papillomavirus) vaginal infection (e.g., that was detected by a positive urine screen for gonorrhea or chlamydial infection, bimanual exam consistent with pelvic inflammatory disease, positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal vaginitis, etc).
• Current or recent abnormal vaginal discharge and /or abnormal vaginal bleeding.
• Had a therapeutic abortion or miscarriage less than 3 months prior.
• Any clinically significant immune suppressing condition.
• Participants with a significant acute condition or any other condition that in the opinion of the Investigator might interfere with the evaluation of the study objectives.
• Women who, in the PI's judgment, would be harmed by the delay in undergoing definitive treatment as a result of study participation and the ABI-2280 Vaginal Tablet dosing schedule.
• Vaccination (even 1 dose) with a prophylactic HPV vaccine (i.e., Gardasil®, Gardasil®-9 or Cervarix®) in the last 3 months.

• Vaccination with a therapeutic HPV vaccine.

  • Other inclusion/exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A1: Single and multiple doses of ABI-2280	Drug: ABI-2280 Vaginal Tablet/Insert; Vaginal Tablet
Experimental: Cohort A2: Multiple doses of ABI-2280	Drug: ABI-2280 Vaginal Tablet/Insert; Vaginal Tablet
Experimental: Cohort A3: Multiple doses of ABI-2280	Drug: ABI-2280 Vaginal Tablet/Insert; Vaginal Tablet
Experimental: Cohort A4: Multiple doses of ABI-2280	Drug: ABI-2280 Vaginal Tablet/Insert; Vaginal Tablet
Experimental: Cohort A5: Multiple doses of ABI-2280	Drug: ABI-2280 Vaginal Tablet/Insert; Vaginal Tablet
Experimental: Cohort A6: Multiple doses of ABI-2280	Drug: ABI-2280 Vaginal Tablet/Insert; Vaginal Tablet
Experimental: Cohort A7: Multiple doses of ABI-2280	Drug: ABI-2280 Vaginal Tablet/Insert; Vaginal Tablet
Experimental: Cohort A8: Intermittent multiple doses of ABI-2280	Drug: ABI-2280 Vaginal Tablet/Insert; Vaginal Tablet
Experimental: Cohort A9: Multiple doses of ABI-2280	Drug: ABI-2280 Vaginal Tablet/Insert; Vaginal Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events (Safety and Tolerability)	For Parts A and B, to assess the safety and tolerability of ABI-2280 Vaginal Tablet by the incidence and severity of Adverse events (AEs).	From Baseline to Day 42 post dose administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathologic changes in cHSIL by large loop excision of the transformation zone (LLETZ) speciment	To assess histopathologic changes in cHSIL by LLETZ	12 weeks after the first dose of ABI-2280 Vaginal Tablet
Pharmacokinetics of ABI-2280 after single and multiple doses	Pharmacokinetics sampling of ABI-2280 will be taken at various time points after single and multiple doses to assess systemic exposure.	PK time points will begin on Day 1 and will continue up to Day 49 (depending on the Cohort)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Endpoint	To evaluate the viral clearance of high-risk human papillomavirus (hrHPV)	hrHPV testing to occur at baseline up to end of study (Day 84)

Collaborators and Investigators

• Sponsor: Antiva Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2022
• Primary Completion (Actual): October 27, 2025
• Study Completion (Actual): October 27, 2025

Study Registration Dates

• First Submitted: August 7, 2022
• First Submitted That Met QC Criteria: August 12, 2022
• First Posted (Actual): August 16, 2022

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Precancerous Conditions; Uterine Cervical Diseases; Uterine Cervical Dysplasia; Investigative Techniques; Genetic Phenomena; Genetic Techniques; Genetic Variation; Protein Engineering; Genetic Engineering; Mutation; Mutagenesis; Mutagenesis, Insertional
• Other Study ID Numbers: ABI-2280-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No