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