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

NCT ID: NCT05502367

Condition: Cervical Intraepithelial Neoplasia

Conditions: Official terms:
Neoplasms
Carcinoma in Situ
Uterine Cervical Dysplasia

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: ABI-2280 Vaginal Tablet/Insert
Description: Vaginal Tablet
Arm group label: Cohort A1: Single and multiple doses of ABI-2280
Arm group label: Cohort A2: Multiple doses of ABI-2280
Arm group label: Cohort A3: Multiple doses of ABI-2280
Arm group label: Cohort A4: Multiple doses of ABI-2280
Arm group label: Cohort A5: Multiple doses of ABI-2280
Arm group label: Cohort A6: Multiple doses of ABI-2280
Arm group label: Cohort A7: Multiple doses of ABI-2280
Arm group label: Cohort A8: Intermittent multiple doses of ABI-2280
Arm group label: Cohort A9: Multiple doses of ABI-2280

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.

Criteria for eligibility:
Criteria:
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

Gender: Female

Minimum age: 25 Years

Maximum age: 55 Years

Healthy volunteers: No

Locations:

Facility:
Name: East Sydney Doctors

Address:
City: Darlinghurst
Zip: 2010
Country: Australia

Status: Recruiting

Contact:
Last name: Heather Farlow

Facility:
Name: CerviCusco

Address:
City: Cusco
Country: Peru

Status: Recruiting

Contact:
Last name: Eliana Ojeda, MD

Facility:
Name: Ginobs S.A.

Address:
City: Lima
Country: Peru

Status: Recruiting

Contact:
Last name: Elena Figueroa Coz

Facility:
Name: Farmovs

Address:
City: Bloemfontein
Zip: 9301
Country: South Africa

Status: Recruiting

Contact:
Last name: Saschke Van der Merwe, MD

Facility:
Name: Nafasi Integrated Solutions

Address:
City: Sunnyside
Zip: 0002
Country: South Africa

Status: Recruiting

Contact:
Last name: Makoma Kenoshi, MD

Facility:
Name: Botho ke Bontle Health Services

Address:
City: Waltloo
Zip: 0184
Country: South Africa

Status: Recruiting

Contact:
Last name: Salphy Mogashoa, MD

Facility:
Name: Gole Biomedical Research Centre

Address:
City: Ga-Mothapo
Country: South Africa

Status: Recruiting

Contact:
Last name: Lorraine Bvuma, MD

Start date: September 10, 2022

Completion date: June 30, 2025

Lead sponsor:
Agency: Antiva Biosciences
Agency class: Industry

Source: Antiva Biosciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05502367

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