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

NCT05502367 | Terminated Phase 1 DMC

• 1 other identifier: ABI-2280-303
• Study Type: interventional
• Target: 44
• Locations: 3 countries
• Sites: 7

Brief Summary

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.

Conditions

Cervical Intraepithelial Neoplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Histopathologic changes in cHSIL by large loop excision of the transformation zone (LLETZ) speciment

  12 weeks after the first dose of ABI-2280 Vaginal Tablet

• Pharmacokinetics of ABI-2280 after single and multiple doses

  PK time points will begin on Day 1 and will continue up to Day 49 (depending on the Cohort)

Other Outcomes (1)

• Exploratory Endpoint

  hrHPV testing to occur at baseline up to end of study (Day 84)

Study Arms (9)

Cohort A1: Single and multiple doses of ABI-2280

EXPERIMENTAL

Drug: ABI-2280 Vaginal Tablet/Insert

Cohort A2: Multiple doses of ABI-2280

EXPERIMENTAL

Drug: ABI-2280 Vaginal Tablet/Insert

Cohort A3: Multiple doses of ABI-2280

EXPERIMENTAL

Drug: ABI-2280 Vaginal Tablet/Insert

Cohort A4: Multiple doses of ABI-2280

EXPERIMENTAL

Drug: ABI-2280 Vaginal Tablet/Insert

Cohort A5: Multiple doses of ABI-2280

EXPERIMENTAL

Drug: ABI-2280 Vaginal Tablet/Insert

Cohort A6: Multiple doses of ABI-2280

EXPERIMENTAL

Drug: ABI-2280 Vaginal Tablet/Insert

Cohort A7: Multiple doses of ABI-2280

EXPERIMENTAL

Drug: ABI-2280 Vaginal Tablet/Insert

Cohort A8: Intermittent multiple doses of ABI-2280

EXPERIMENTAL

Drug: ABI-2280 Vaginal Tablet/Insert

Cohort A9: Multiple doses of ABI-2280

EXPERIMENTAL

Drug: ABI-2280 Vaginal Tablet/Insert

Interventions

ABI-2280 Vaginal Tablet/Insert DRUG

Vaginal Tablet

Cohort A1: Single and multiple doses of ABI-2280; Cohort A2: Multiple doses of ABI-2280; Cohort A3: Multiple doses of ABI-2280; Cohort A4: Multiple doses of ABI-2280; Cohort A5: Multiple doses of ABI-2280; Cohort A6: Multiple doses of ABI-2280; Cohort A7: Multiple doses of ABI-2280; Cohort A8: Intermittent multiple doses of ABI-2280; Cohort A9: Multiple doses of ABI-2280

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Antiva Biosciences: lead

Study Sites (7)

East Sydney Doctors

Darlinghurst, New South Wales, 2010, Australia

Location

CerviCusco

Cusco, Peru

Location

Ginobs S.A.

Lima, Peru

Location

Farmovs

Bloemfontein, Free State, 9301, South Africa

Location

Nafasi Integrated Solutions

Sunnyside, Gauteng, 0002, South Africa

Location

Botho ke Bontle Health Services

Waltloo, Gauteng, 0184, South Africa

Location

Gole Biomedical Research Centre

Ga-Mothapo, Limpopo, South Africa

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Protein Engineering; Genetic Engineering; Genetic Techniques; Investigative Techniques; Mutation; Genetic Variation; Genetic Phenomena; Mutagenesis

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 16, 2022
• Study Start: September 10, 2022
• Primary Completion: October 27, 2025
• Study Completion: October 27, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PE (2); ZA (4); AU (1)