A Phase I/Ib Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Ductal Carcinoma in Situ and Lobular Carcinoma in Situ
Providence Health & Services
Summary
This is a Phase I/Ib study evaluating CAN1012 in patients with ductal carcinoma in situ and lobular carcinoma in situ.
Description
This is not a dose finding study, and therefore patients may be enrolled to any of the four arms in any order, based on clinical considerations (e.g. OR scheduling). No arm, per specific disease type, may expand beyond the first 3 patients, until 30-day post-op safety evaluation has been completed. Study analysis is planned after a single dose of intralesional CAN1012. The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection. The study will be stopped early for patient safety according to stopping rules be…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female patients with DCIS or LCIS found on core biopsy. 2. Tumor types allowed: Biopsy-identified DCIS or LCIS comprising a single lesion ≥ 1 cm and ≤ 5 cm in size by imaging (mammogram or MRI or ultrasound (US)) without evidence of invasive disease on the biopsy and US negative for suspicious ipsilateral lymph nodes. 3. Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document. 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designe…
Interventions
- DrugCAN1012
CAN1012 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.
Location
- Providence Portland Cancer Institute - Franz ClinicPortland, Oregon