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An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101

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ClinicalTrials.gov Identifier: NCT02065973
Recruitment Status : Unknown
Verified February 2014 by PDS Biotechnology Corp..
Recruitment status was:  Enrolling by invitation
First Posted : February 19, 2014
Last Update Posted : February 19, 2014
Sponsor:
Information provided by (Responsible Party):
PDS Biotechnology Corp.

Brief Summary:
Phase I, open-label, sequential-cohort, ascending multiple-dose study to evaluate the safety and tolerability of escalating doses of PDS0101 in female subjects with high-risk HPV infection and biopsy-proven CIN1. The study will include 3 cohorts of 3 to 6 subjects each based on a modified "3 + 3" dose-escalation study design. The study will be initiated with Cohort 1 and progress through Cohort 3, with each subsequent cohort receiving a higher dose of PDS0101. Successive cohorts will receive a constant dose of HPV-16 E6 and E7 peptides. All subjects will receive 3 vaccinations SC given approximately 21 days apart. Dosing and dose escalation will be based on safety evaluation for determination of potential dose-limiting toxicity (DLT).

Condition or disease Intervention/treatment Phase
Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101 in Female Subjects With High-risk HPV Infection and Biopsy-proven CIN1. Biological: R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101 in Subjects With Cervical Intraepithelial Neoplasia (CIN) and High-risk Human Papillomavirus (HPV) Infection
Study Start Date : February 2014
Estimated Primary Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Cohort 1 (Low Dose)
The group will receive the lowest dose of the vaccine
Biological: R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7
Active Comparator: Cohort 2 (Mid Dose)
The Group will receive the middle dose of the vaccine
Biological: R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7
Active Comparator: Cohort 3 (High Dose)
The Group will receive the highest dose of vaccine to be tested
Biological: R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7



Primary Outcome Measures :
  1. Evaluation or determination of adverse events following vaccination [ Time Frame: Days 1-133 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Written informed consent prior to initiation of any study-related procedures;
  2. Nonlactating female between the ages of 21 to 65 years, inclusive;
  3. Non-childbearing potential (defined as surgically sterile or at least 2 years postmenopausal) or practicing effective contraception (defined as 2 concurrent methods of contraception, 1 of which is a barrier method) and agrees to continue using effective contraception throughout the duration of the study;
  4. Not pregnant based on a negative result on a serum human chorionic gonadotropin (HCG) test at screening Visit 1 and a negative urine pregnancy test prevaccination at Visit 2 (and at subsequent vaccination visits);
  5. Pap test documenting atypical squamous cells of undetermined significance (ASCUS)/HPV+, atypical squamous cells high grade (ASC-H), low-grade squamous intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL) within 4 months prior to screening Visit 1;
  6. History of pathologically confirmed CIN1 by colposcopically-directed punch biopsy, within 12 weeks prior to administration of first study vaccination (CIN 2/3 subjects will not be eligible);
  7. For the diagnosis of CIN1, has a documented satisfactory colposcopy, ie, the entire lesion as well as the entire squamocolumnar junction is visualizible by colposcopy;
  8. Confirmed high-risk HPV infection by a commercially available high-risk DNA assay (eg, Hybrid Capture II [Qiagen]);
  9. Good health with adequate hematologic, renal, hepatic, and cardiac function, as determined by the Investigator, based upon medical history, physical examination, and laboratory test results at the screening visit (Visit 1):

    • Bone marrow function: absolute neutrophil count ≥1,500/µL, and platelets ≥ 100,000/ µL;
    • Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN);
    • Hepatic function: total bilirubin ≤ 1.5 x ULN (Common Terminology Criteria for AEs [CTCAE] v4.0 grade 1) except patients with Gilbert's disease (up to 5.0 mg/dL). Aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN.
    • Normal Cardiac function: as assessed by history and physical exam.

Exclusion Criteria:

  1. Atypical endometrial or glandular cells or evidence of invasive cervical carcinoma on cervical biopsy;
  2. Previous history of cancer, other than adequately treated basal cell or Stage 1 squamous cell carcinoma of the skin;
  3. Current recognized immunodeficiency disease, including infection with HIV, cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies.
  4. Received immunotherapy (eg, IFNs, tumor necrosis factor, interleukins, or biological response modifiers [granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, macrophage colony-stimulating factor]) within 30 days prior to administration of the first study vaccination;
  5. Serious, concomitant disorder, including active systemic infection requiring treatment, in the opinion of the investigator;
  6. Currently receiving or has received treatment with systemic steroids in the following dosages within 30 days prior to administration of the first study vaccination.

    • Chronic or long-term corticosteroids: ≥0.5 mg/kg/day of oral prednisolone or equivalent
    • Sporadic corticosteroids: ≥1 mg/kg/day of oral prednisolone or equivalent for 2 or more short courses of > 3 days
    • Note: Current or recent use of intra-articular, topical or inhaled glucocorticoid therapy is acceptable;
  7. Other condition or prior therapy that, in the opinion of the Investigator, compromises the subject's welfare or may confound study results;
  8. Participation in another investigational study concurrently or use of another investigational drug within 6 months prior to administration of the first study vaccination;
  9. Previously enrolled in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065973


Locations
United States, New York
Suffolk Obstetrics & Gynecology
Port Jefferson, New York, United States, 11777
Sponsors and Collaborators
PDS Biotechnology Corp.

Responsible Party: PDS Biotechnology Corp.
ClinicalTrials.gov Identifier: NCT02065973     History of Changes
Other Study ID Numbers: U10-02-11-001
First Posted: February 19, 2014    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Infection
Cervical Intraepithelial Neoplasia
Papillomavirus Infections
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
DNA Virus Infections
Virus Diseases
Tumor Virus Infections