CAN1012 in Pre-malignant Oral Dysplasia

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorProvidence Health & Services

About this trial

The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection.

Eligibility criteria

Qualifiers

Clinically-identified oral epithelial dysplasia (OED)

Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.

Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.

WBC ≥ 2.0 K/µL, ANC ≥ 1.0 K/µL

Disqualifiers

Any serious underlying medical or psychiatric condition that, in the opinion of the investigator, would pose a risk to patient safety or interfere with the study procedures, completion, or evaluation.

Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.

Need for hormonal contraception including oral contraceptives, implant, injectable depots, vaginal rings, skin patches, and the progestin IUD; or any medication that is a sensitive substrate of the major CYPs.

History of or current active autoimmune diseases which, in the judgment of the investigator, pose an active and significant risk. Vitiligo, lichen planus or lichenoid inflammation, and adequately controlled endocrine deficiencies such as hypothyroidism/ hyperthyroidism are not exclusionary.

Trial design

Treatments tested in this trial

  • CAN1012

Treatment groups

36 Participants
are divided into 4 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Providence Health & Services

Lead sponsor

CanWell Pharma Inc.

Collaborator