A Phase 1 interventional study of CAN1012 in Oral Epithelial Dysplasia (OED), sponsored by Providence Health & Services. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Providence Health & Services · Phase 1, Interventional, and Treatment
The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection.
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 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.
Laboratory values within 72 hours of Day 0:
Exclusion Criteria:
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.
Drug: CAN1012
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.
Drug: CAN1012
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.
Drug: CAN1012
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.
Drug: CAN1012
CAN1012 is an IFN-α biased, long-acting, highly selective TLR7 agonist, which acts as an immune modulator capable of priming both innate and adaptive immunity against tumors. It has previously been shown on intralesional injection to turn "cold" tumors "hot" through several mechanisms: 1. CAN1012 activates plasmacytoid dendritic cells (pDCs), producing robust IFN-α but minimal IL-6 or TNF; 2. IFN-α primes NK and CD8+ T cell maturation and release of cytotoxic granules to kill tumor cells; 3. IFN-α promotes mature cDCs to migrate to tumor draining lymph nodes and present tumor antigens to CD4+ T cells; 4. Chemokines induced by TLR7 stimulation recruit inflammatory cells into the tumor microenvironment (TME).
Safety and Tolerability
Assess safety \& tolerability of intralesional CAN1012 injection in subjects with OED by monitoring for adverse events and delays in surgery. Adverse events will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v6.0 and the Clavien-Dindo grading tool will be used for surgical complications.
Time frame: Post-operative follow-up visit (30 days after surgery)
Immunologic Monitoring
Flow cytometric analysis on pre/post whole blood, and tandem pre/post Multiplex IF for quantitative immunophenotyping, will be performed to ascertain if TLR7 agonists deplete immunosuppressive immune populations within the tumor and if the multiplex immunofluorescence (mIF) changes in the tumor will not be detectable in peripheral blood.
Time frame: 5 years
LINE-1 Expression
LINE-1 (L1) expression at the protein level will be evaluated using multiplex IF. Paraffin-embedded tissue blocks will be utilized for multiplex IF using the Lunaphore COMET platform.
Time frame: 5 years
Relapse Free Survival (RFS)
Assess whether recurrence of OED or invasive disease (relapse free survival, RFS) within the 5 years of the trial.
Time frame: 5 years
No study locations are listed for this record.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Providence Health & Services