A Study of ABI-2280 Vaginal Insert (Previously Referred to as ABI-2280 Vaginal Tablet) in Participants With Cervical Intraepithelial Neoplasia
NCT ID: NCT05502367
Last Updated: 2024-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
110 participants
INTERVENTIONAL
2022-09-10
2025-06-30
Brief Summary
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Part A consists of up to 9 dose escalation cohorts. Part B consists of dose expansion cohorts.
Participants will self-administer ABI-2280.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort A1: Single and multiple doses of ABI-2280
ABI-2280 Vaginal Tablet/Insert
Vaginal Tablet
Cohort A2: Multiple doses of ABI-2280
ABI-2280 Vaginal Tablet/Insert
Vaginal Tablet
Cohort A3: Multiple doses of ABI-2280
ABI-2280 Vaginal Tablet/Insert
Vaginal Tablet
Cohort A4: Multiple doses of ABI-2280
ABI-2280 Vaginal Tablet/Insert
Vaginal Tablet
Cohort A5: Multiple doses of ABI-2280
ABI-2280 Vaginal Tablet/Insert
Vaginal Tablet
Cohort A6: Multiple doses of ABI-2280
ABI-2280 Vaginal Tablet/Insert
Vaginal Tablet
Cohort A7: Multiple doses of ABI-2280
ABI-2280 Vaginal Tablet/Insert
Vaginal Tablet
Cohort A8: Intermittent multiple doses of ABI-2280
ABI-2280 Vaginal Tablet/Insert
Vaginal Tablet
Cohort A9: Multiple doses of ABI-2280
ABI-2280 Vaginal Tablet/Insert
Vaginal Tablet
Interventions
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ABI-2280 Vaginal Tablet/Insert
Vaginal Tablet
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
25 Years
55 Years
FEMALE
No
Sponsors
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Antiva Biosciences
INDUSTRY
Responsible Party
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Locations
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East Sydney Doctors
Darlinghurst, New South Wales, Australia
CerviCusco
Cusco, , Peru
Ginobs S.A.
Lima, , Peru
Farmovs
Bloemfontein, Free State, South Africa
Nafasi Integrated Solutions
Sunnyside, Gauteng, South Africa
Botho ke Bontle Health Services
Waltloo, Gauteng, South Africa
Gole Biomedical Research Centre
Ga-Mothapo, Limpopo, South Africa
Countries
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Central Contacts
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Facility Contacts
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Heather Farlow
Role: primary
Eliana Ojeda, MD
Role: primary
Elena Figueroa Coz
Role: primary
Saschke Van der Merwe, MD
Role: primary
Makoma Kenoshi, MD
Role: primary
Salphy Mogashoa, MD
Role: primary
Lorraine Bvuma, MD
Role: primary
Other Identifiers
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ABI-2280-303
Identifier Type: -
Identifier Source: org_study_id
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