About this trial

This is a Phase I/Ib study evaluating CAN1012 in patients with ductal carcinoma in situ and lobular carcinoma in situ.

Eligibility criteria

Qualifiers

Male or female patients with DCIS or LCIS found on core biopsy.

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

24 Participants
are divided into 4 treatment groups

Locations

1
Providence Portland Cancer Institute - Franz Clinic97213, PortlandOregon, United States

Sponsors and collaborators

Providence Health & Services

Lead sponsor

CanWell Pharma Inc.

Collaborator