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CAN1012 in OED, DCIS, and LCIS. | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1

CAN1012 in OED, DCIS, and LCIS.

A Phase I/Ib Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Oral Epithelial Dysplasia, Ductal Carcinoma in Situ, and Lobular Carcinoma in Situ

NCT07408856•Providence Health & Services

View on ClinicalTrials.gov

Summary

This is a Phase I/Ib study evaluating CAN1012 in patients with oral epithelial dysplasia, ductal carcinoma in situ, and lobular carcinoma in situ.

Detailed 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 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. The 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. The 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. The 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Tumor types allowed:
•1. Clinically-identified oral epithelial dysplasia (OED), or
•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.
•2. Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.
•3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.
•4. Laboratory values within 72 hours of Day 0:
•1. WBC ³ 2.0 K/µL, ANC ³ 1.0 K/µL
•2. Hgb ≥ 10 g/dL
•3. Platelets ³ 100,000 K/µL
•4. Creatinine £ 1.5 x ULN
+4 more criteria

Exclusion Criteria

•1. 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.
•2. Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.
•3. 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.
•4. 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.
•5. Previous history of bone marrow transplantation or oral Graft Versus Host Disease (GVHD).
•6. Has an active infection requiring systemic therapy. Investigator may allow if deemed not clinically significant.
•7. Has a known history of Human Immunodeficiency Virus (HIV). Testing is not required unless mandated by local health authority.
•8. 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.
•9. 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.
•10. 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.

Locations (1)

Providence Portland Cancer Institute - Franz Clinic

Portland, Oregon, United States

Key Dates

Start Date

May 1, 2026

Primary Completion Date

May 1, 2030

Completion Date

May 1, 2035

Last Updated

February 13, 2026

Enrollment

ESTIMATED participants

Conditions

Oral Epithelial DysplasiaDuctal Carcinoma in SituLobular Carcinoma in Situ

Interventions

CAN1012 (.2 mL)

DRUG

CAN1012 (.4 mL)

DRUG

Contacts

Isa Ngirailemesang, RN

CONTACT

503-215-1979 canrsrchstudies@providence.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

CAN1012 in OED, DCIS, and LCIS.

Inclusion Criteria

Exclusion Criteria

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