CAN1012 in Pre-Malignant DCIS and LCIS
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorProvidence Health & Services
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 groupsSponsors and collaborators
Providence Health & Services
Lead sponsor
CanWell Pharma Inc.
Collaborator
Source ClinicalTrials.gov