[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624378":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":89,"collaborators":91,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":32,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":32,"enrollmentInfo":104,"targetDuration":32,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":32,"overallStatus":114,"whyStopped":32,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Providence Health & Services","OTHER",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Day 2-3","EXPERIMENTAL","Injection of CAN1012 into target lesion will occur on Day 0. Specimens collected during Standard of Care (SOC) resection will be evaluated for immunologic changes compared to baseline on Days 2-3.",[13],"Drug: CAN1012",{"label":15,"type":10,"description":16,"interventionNames":17},"Arm B: Day 5-7","Injection of CAN1012 into target lesion will occur on Day 0. Specimens collected during Standard of Care (SOC) resection will be evaluated for immunologic changes compared to baseline on Days 5-7.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Arm C: Day 9-11","Injection of CAN1012 into target lesion will occur on Day 0. Specimens collected during Standard of Care (SOC) resection will be evaluated for immunologic changes compared to baseline on Days 9-11.",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Arm D: Day 13-15","Injection of CAN1012 into target lesion will occur on Day 0. Specimens collected during Standard of Care (SOC) resection will be evaluated for immunologic changes compared to baseline on Days 13-15.",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","CAN1012","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.",[9,15,19,23],null,[34],{"name":35,"affiliation":5,"role":36},"Sasha Stanton, MD, PhD","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},"Isa Ngirailemesang, RN","CONTACT","503-215-1979","canrsrchstudies@providence.org",[44],{"facility":45,"status":32,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Providence Portland Cancer Institute - Franz Clinic","Portland","Oregon","97213","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-122.67621,45.52345,{"lat":55,"lon":54},[58,59,60,63,65,67,69,71,73,75,77,79,81,83,85,87],{"name":39,"role":40,"phone":41,"phoneExt":32,"email":42},{"name":35,"role":36,"phone":32,"phoneExt":32,"email":32},{"name":61,"role":62,"phone":32,"phoneExt":32,"email":32},"RaYoung Chung, NP","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":32,"phoneExt":32,"email":32},"Alison Conlin, MD",{"name":66,"role":62,"phone":32,"phoneExt":32,"email":32},"Brendan Curti, MD",{"name":68,"role":62,"phone":32,"phoneExt":32,"email":32},"Molly Davis, NP",{"name":70,"role":62,"phone":32,"phoneExt":32,"email":32},"Roxanne Griswold, NP",{"name":72,"role":62,"phone":32,"phoneExt":32,"email":32},"Amy Hartman, NP",{"name":74,"role":62,"phone":32,"phoneExt":32,"email":32},"Rom Leidner, MD",{"name":76,"role":62,"phone":32,"phoneExt":32,"email":32},"Rui Li, MD, PhD",{"name":78,"role":62,"phone":32,"phoneExt":32,"email":32},"Mary Martel, NP",{"name":80,"role":62,"phone":32,"phoneExt":32,"email":32},"Jamie Martinez, NP",{"name":82,"role":62,"phone":32,"phoneExt":32,"email":32},"David Page, MD",{"name":84,"role":62,"phone":32,"phoneExt":32,"email":32},"Rachel Sanborn, MD",{"name":86,"role":62,"phone":32,"phoneExt":32,"email":32},"Matthew Taylor, MD",{"name":88,"role":62,"phone":32,"phoneExt":32,"email":32},"Binbin Zheng, MD",{"type":90,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[92],{"name":93,"class":94},"CanWell Pharma Inc.","INDUSTRY","100624378","phase-1-can1012-in-pre-malignant-dcis-and-lcis-100624378",false,"NCT07408856","CAN1012 in Pre-Malignant DCIS and LCIS","A Phase I\u002FIb Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Ductal Carcinoma in Situ and Lobular Carcinoma in Situ","Inclusion Criteria:\n\n1. Male or female patients with DCIS or LCIS found on core biopsy.\n2. Tumor types allowed:\n\n   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.\n3. Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.\n5. Laboratory values within 72 hours of Day 0:\n\n   1. WBC ≥ 2.0 K\u002FµL, ANC ≥ 1.0 K\u002FµL\n   2. Hgb ≥ 10 g\u002FdL\n   3. Platelets ≥ 100,000 K\u002FµL\n   4. Creatinine Clearance (using Cockcroft-Gault) ≥ 60.\n   5. AST\u002FALT ≤ 2.5 x ULN\n   6. Total bilirubin ≤ 3 x ULN, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg\u002FdL)\n   7. Negative pregnancy test for people of childbearing potential (bHCG urine or serum)\n6. Patients and their partners who are capable of conceiving must agree to use effective methods of contraception (non-hormonal only) during the course of treatment and for 165 days after last dose of CAN1012.\n\nExclusion Criteria:\n\n1. 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.\n2. Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.\n3. 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.\n4. 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\u002Fhyperthyroidism are not exclusionary.\n5. Previous history of bone marrow transplantation or oral Graft Versus Host Disease (GVHD).\n6. Has an active infection requiring systemic therapy. Investigator may allow if deemed not clinically significant.\n7. Has active or uncontrolled Hepatitis B, Hepatitis C, or HIV with AIDS (acquired immunodeficiency syndrome)- defined opportunistic infection.\n8. Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known history of Hepatitis C virus (defined as HCV RNA) infection. Testing for Hepatitis B and Hepatitis C is not required unless mandated by local health authority.\n9. Has a baseline electrocardiogram (ECG) with a prolonged QTc interval \\> 480 msec. Medications which have a known and clinically significant risk of QT prolongation may be allowed per investigator discretion.\n10. Patients who have had a history of acute diverticulitis, intra-abdominal abscess, GI obstruction and abdominal carcinomatosis which are known risk factors for bowel perforation, and in the judgment of the investigator still pose an active risk.","ALL","18 Years",{"count":105,"type":106},24,"ESTIMATED","INTERVENTIONAL",[109],"PHASE1","This is a Phase I\u002FIb study evaluating CAN1012 in patients with ductal carcinoma in situ and lobular carcinoma in situ.",[112,113],"Ductal Carcinoma in Situ","Lobular Carcinoma in Situ","NOT_YET_RECRUITING","2026-04-02",{"date":117,"type":118},"2026-04-08","ACTUAL",{"date":120,"type":106},"2026-05",{"date":122,"type":106},"2035-05",{"name":5,"class":6},1]