Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:35 AM
Study NCT ID:
NCT07408856
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAN1012 in OED, DCIS, and LCIS.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002285', 'term': 'Carcinoma, Intraductal, Noninfiltrating'}, {'id': 'D000071960', 'term': 'Breast Carcinoma In Situ'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D002278', 'term': 'Carcinoma in Situ'}, {'id': 'D018299', 'term': 'Neoplasms, Ductal, Lobular, and Medullary'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2035-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of CAN1012', 'timeFrame': 'Post-operative follow-up visit (30 days after surgery)', 'description': 'Safety will be measured by demonstrating that there is a less than 33% rate of delayed surgery attributable to the study treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Epithelial Dysplasia', 'Ductal Carcinoma in Situ', 'Lobular Carcinoma in Situ']}, 'descriptionModule': {'briefSummary': 'This is a Phase I/Ib study evaluating CAN1012 in patients with oral epithelial dysplasia, ductal carcinoma in situ, and lobular carcinoma in situ.', 'detailedDescription': '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.\n\nThe 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 below. The sample size for the study is not based on any statistical assumptions. The number of subjects is based on the number of cohorts tested and the size of each cohort.\n\nThe Safety Analysis Set will consist of all subjects who receive at least one dose of study treatment. The Safety Analysis Set will be used for safety analyses.\n\nThe Intent-to-treat (ITT) Analysis Set will consist of all subjects who receive at least one dose of study treatment and have at least one post-Baseline assessment of tumor response.\n\nThe disposition of subjects will be summarized by presenting the number of subjects enrolled, the number and percentage of subjects in each analysis population, the number for whom the study drug was discontinued with the reasons for discontinuation, and the number of subjects who discontinued participation in the study with the reason(s) for withdrawal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Tumor types allowed:\n\n 1. Clinically-identified oral epithelial dysplasia (OED), or\n 2. Biopsy-identified DCIS or LCIS comprising a single lesion ≥ 2 cm in size by imaging (mammogram or MRI) without evidence of invasive disease on the biopsy and US negative for enlarged ipsilateral lymph nodes.\n2. Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.\n4. Laboratory values within 72 hours of Day 0:\n\n 1. WBC ³ 2.0 K/µL, ANC ³ 1.0 K/µL\n 2. Hgb ≥ 10 g/dL\n 3. Platelets ³ 100,000 K/µL\n 4. Creatinine £ 1.5 x ULN\n 5. AST/ALT £ 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/dL)\n 7. Negative pregnancy test (bHCG urine or serum, people of childbearing potential only)\n5. Patients and their partners who are sexually active and capable of conceiving must agree to use effective methods of contraception (non-hormonal only for DCIS and LCIS patients) 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/hyperthyroidism 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 a known history of Human Immunodeficiency Virus (HIV). Testing is not required unless mandated by local health authority.\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."}, 'identificationModule': {'nctId': 'NCT07408856', 'briefTitle': 'CAN1012 in OED, DCIS, and LCIS.', 'organization': {'class': 'OTHER', 'fullName': 'Providence Health & Services'}, 'officialTitle': 'A Phase I/Ib Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Oral Epithelial Dysplasia, Ductal Carcinoma in Situ, and Lobular Carcinoma in Situ', 'orgStudyIdInfo': {'id': '2025001065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Oral Epithelial Dysplasia Patients', 'description': 'Up to 36 oral epithelial dysplasia patients will be enrolled. For oral epithelial dysplasia patients, treating investigator may opt to defer surgery and pursue additional injections.', 'interventionNames': ['Drug: CAN1012 (.2 mL)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B: Ductal Carcinoma in Situ Patients', 'description': 'Up to 12 ductal carcinoma in situ patients will be enrolled.', 'interventionNames': ['Drug: CAN1012 (.4 mL)']}, {'type': 'EXPERIMENTAL', 'label': 'Arm C: Lobular Carcinoma in Situ Patients', 'description': 'Up to 12 lobular carcinoma in situ patients will be enrolled.', 'interventionNames': ['Drug: CAN1012 (.4 mL)']}], 'interventions': [{'name': 'CAN1012 (.2 mL)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Arm A: Oral Epithelial Dysplasia Patients']}, {'name': 'CAN1012 (.4 mL)', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Arm B: Ductal Carcinoma in Situ Patients', 'Arm C: Lobular Carcinoma in Situ Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'contacts': [{'name': 'Isa Ngirailemesang, RN', 'role': 'CONTACT', 'email': 'canrsrchstudies@providence.org', 'phone': '503-215-1979'}, {'name': 'Sasha Stanton, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'RaYoung Chung, NP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alison Conlin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Brendan Curti, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Molly Davis, NP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Roxanne Griswold, NP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amy Hartman, NP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rom Leidner, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rui Li, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mary Martel, NP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jamie Martinez, NP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Page, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Rachel Sanborn, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Matthew Taylor, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Binbin Zheng, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Providence Portland Cancer Institute - Franz Clinic', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}], 'centralContacts': [{'name': 'Isa Ngirailemesang, RN', 'role': 'CONTACT', 'email': 'canrsrchstudies@providence.org', 'phone': '503-215-1979'}], 'overallOfficials': [{'name': 'Sasha Stanton, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Providence Health & Services'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Providence Health & Services', 'class': 'OTHER'}, 'collaborators': [{'name': 'CanWell Pharma Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}