CAN1012 in Pre-Malignant DCIS and LCIS
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CAN1012
DrugCAN1012 is a IFN-a biased, long-acting, highly selective TLR7 agonist, which acts as an immune modulator capable of priming both innate and adaptive immunity against tumors. CAN1012 will be administered as an injection directly into the target lesion prior to surgery.
Treatment groups
24 Participants
are divided into 4 treatment groupsGroup A: Arm A: Day 2-3Experimental treatment 1 intervention
Group B: Arm B: Day 5-7Experimental treatment 1 intervention
Group C: Arm C: Day 9-11Experimental treatment 1 intervention
Group D: Arm D: Day 13-15Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety of CAN1012
Safety will be measured by demonstrating that there is a less than 33% rate of delayed surgery attributable to the study treatment.
Time frame
Post-operative follow-up visit (30 days after surgery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Providence Health & Services
Lead sponsor
CanWell Pharma Inc.
Collaborator
Source ClinicalTrials.gov