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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05502367




Registration number
NCT05502367
Ethics application status
Date submitted
7/08/2022
Date registered
16/08/2022

Titles & IDs
Public title
A Study of ABI-2280 Vaginal Insert (Previously Referred to as ABI-2280 Vaginal Tablet) in Participants With Cervical Intraepithelial Neoplasia
Scientific title
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
Secondary ID [1] 0 0
ABI-2280-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cervical Intraepithelial Neoplasia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Cervical (cervix)
Cancer 0 0 0 0
Breast
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABI-2280

Experimental: ABI-2280 0.1mg - 0.1mg vaginal tablet

Experimental: ABI-2280 0.3mg - 0.3mg vaginal tablet

Experimental: ABI-2280 1.0mg - 1.0mg vaginal tablet


Treatment: Drugs: ABI-2280
Vaginal Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of Adverse Events (Safety and Tolerability)
Timepoint [1] 0 0
From Baseline to Day 42 post dose administration
Secondary outcome [1] 0 0
Pharmacokinetics of ABI-2280 after single and multiple doses
Timepoint [1] 0 0
60 minutes prior to dosing on Day 1, and 1 hour (± 5 mins) and 6 hours (± 1 hour) post-dose on Day 1. For Part A, additional samples will be taken at 2 hours (± 5 mins) and 24 hours (± 2 hours) post dose on Day 1.
Secondary outcome [2] 0 0
Pharmacokinetics of ABI-2280 after single and multiple doses
Timepoint [2] 0 0
60 minutes prior to dosing on Day 1, and 1 hour (± 5 mins) and 6 hours (± 1 hour) post-dose on Day 1. For Part A, additional samples will be taken at 2 hours (± 5 mins) and 24 hours (± 2 hours) post dose on Day 1.
Secondary outcome [3] 0 0
Pharmacokinetics of ABI-2280 after single and multiple doses
Timepoint [3] 0 0
60 minutes prior to dosing on Day 1, and 1 hour (± 5 mins) and 6 hours (± 1 hour) post-dose on Day 1. For Part A, additional samples will be taken at 2 hours (± 5 mins) and 24 hours (± 2 hours) post dose on Day 1.
Secondary outcome [4] 0 0
Pharmacokinetics of ABI-2280 after single and multiple doses
Timepoint [4] 0 0
60 minutes prior to dosing on Day 1, and 1 hour (± 5 mins) and 6 hours (± 1 hour) post-dose on Day 1. For Part A, additional samples will be taken at 2 hours (± 5 mins) and 24 hours (± 2 hours) post dose on Day 1.
Secondary outcome [5] 0 0
Pharmacokinetics of ABI-2280 after single and multiple doses
Timepoint [5] 0 0
60 minutes prior to dosing on Day 1, and 1 hour (± 5 mins) and 6 hours (± 1 hour) post-dose on Day 1. For Part A, additional samples will be taken at 2 hours (± 5 mins) and 24 hours (± 2 hours) post dose on Day 1.
Secondary outcome [6] 0 0
Pharmacokinetics of ABI-2280 after single and multiple doses
Timepoint [6] 0 0
60 minutes prior to dosing on Day 1, and 1 hour (± 5 mins) and 6 hours (± 1 hour) post-dose on Day 1. For Part A, additional samples will be taken at 2 hours (± 5 mins) and 24 hours (± 2 hours) post dose on Day 1.
Secondary outcome [7] 0 0
Pharmacokinetics of ABI-2280 after single and multiple doses
Timepoint [7] 0 0
60 minutes prior to dosing on Day 1, and 1 hour (± 5 mins) and 6 hours (± 1 hour) post-dose on Day 1. For Part A, additional samples will be taken at 2 hours (± 5 mins) and 24 hours (± 2 hours) post dose on Day 1.
Secondary outcome [8] 0 0
Pharmacokinetics of ABI-2280 after single and multiple doses
Timepoint [8] 0 0
60 minutes prior to dosing on Day 1, and 1 hour (± 5 mins) and 6 hours (± 1 hour) post-dose on Day 1. For Part A, additional samples will be taken at 2 hours (± 5 mins) and 24 hours (± 2 hours) post dose on Day 1.
Secondary outcome [9] 0 0
Histopathologic changes in cHSIL by large loop excision of the transformation zone (LLETZ) specimen
Timepoint [9] 0 0
12 weeks after the first dose of ABI-2280 Vaginal Tablet

Eligibility
Key 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.
Minimum age
25 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/09/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
110
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
East Sydney Doctors - Darlinghurst
Recruitment hospital [2] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
South Africa
State/province [1] 0 0
Free State

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Antiva Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Annie Warsi, MD
Address 0 0
Country 0 0
Phone 0 0
408-401-6086
Fax 0 0
Email 0 0
awarsi@antivabio.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05502367