Oral Epithelial Dysplasia (OED)Phase 1NCT07620496
CAN1012 in Pre-malignant Oral Dysplasia
A Phase 1 study testing CAN1012 in people with Oral Epithelial Dysplasia (OED), run by Providence Health & Services.
Trial summary
The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Epithelial Dysplasia (OED)
- What is being tested?
- CAN1012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to Jul 2033
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically-identified oral epithelial dysplasia (OED)
- Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.
- Laboratory values within 72 hours of Day 0:
- WBC ≥ 2.0 K/µL, ANC ≥ 1.0 K/µL
- Hgb ≥ 10 g/dL
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- Platelets ≥ 100,000 K/µL
- Creatinine Clearance (using Cockcroft-Gault)
- AST/ALT ≤ 2.5 x ULN
- Total bilirubin ≤ 3 x ULN, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
- Negative pregnancy test (bHCG urine or serum, people of childbearing potential only)
- Patients and their partners who are capable of conceiving must agree to use effective methods of during the course of treatment and for 165 days after last dose of CAN1012.
Who cannot join
- 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.
- Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.
- 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.
- 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.
- Previous history of bone marrow transplantation or oral Graft Versus Host Disease (GVHD).
- Has an active infection requiring systemic therapy. Investigator may allow if deemed not clinically significant.
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- Has active or uncontrolled Hepatitis B, Hepatitis C, or HIV with AIDS (acquired immunodeficiency syndrome)- defined opportunistic infection.
- 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.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/Ib Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Oral Dysplasia
The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection.
Read the 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 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.
- Conditions
- Oral Epithelial Dysplasia (OED)
- Being tested
- CAN1012
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAN1012Drug
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:
- CAN1012 activates plasmacytoid dendritic cells (pDCs), producing robust IFN-α but minimal IL-6 or TNF;
- IFN-α primes NK and CD8+ T cell maturation and release of cytotoxic granules to kill tumor cells;
- IFN-α promotes mature cDCs to migrate to tumor draining lymph nodes and present tumor antigens to CD4+ T cells;
- Chemokines induced by TLR7 stimulation recruit inflammatory cells into the tumor microenvironment (TME).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: CAN1012 |
| Arm B: Day 5-7 | 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 5-7. Receives: Drug: CAN1012 |
| Arm C: Day 9-11 | 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 9-11. Receives: Drug: CAN1012 |
| Arm D: Day 13-15 | 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 13-15. Receives: Drug: CAN1012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-operative follow-up visit (30 days after surgery)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completionJul 2031 (estimated)
- Study completionJul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Epithelial Dysplasia (OED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- CanWell Pharma Inc.
- Responsible party
- Sponsor
- Investigators
- Sasha Stanton, MD, PhD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07620496
- Sponsor's protocol ID
- 2026000210
- Status last verified
- May 2026
- First submitted
- 2 Apr 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Oral Dysplasia
- ClinicalTrials.gov ID
- NCT07620496
- Acronym / sponsor ID
- 2026000210
- Conditions
- Oral Epithelial Dysplasia (OED)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- CanWell Pharma Inc.
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- Jul 2031 (estimated)
- Study completion
- Jul 2033 (estimated)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Day 2-3 | Experimental | Drug: CAN1012Injection 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. |
| Arm B: Day 5-7 | Experimental | Drug: CAN1012Injection 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. |
| Arm C: Day 9-11 | Experimental | Drug: CAN1012Injection 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. |
| Arm D: Day 13-15 | Experimental | Drug: CAN1012Injection 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Clinically-identified oral epithelial dysplasia (OED)
- Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.
- Laboratory values within 72 hours of Day 0:
- Patients and their partners who are capable of conceiving must agree to use effective methods of during the course of treatment and for 165 days after last dose of CAN1012.
Key exclusion criteria (9 listed)
- 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.
- Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.
- 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.
- 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.
- Previous history of bone marrow transplantation or oral Graft Versus Host Disease (GVHD).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAN1012CAN1012 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). | Drug | Arm A: Day 2-3, Arm B: Day 5-7, Arm C: Day 9-11, Arm D: Day 13-15 |
Primary outcome
Safety and Tolerability
Time frame: Post-operative follow-up visit (30 days after surgery)
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.
3 secondary outcomes
Immunologic Monitoring
Time frame: 5 years
LINE-1 Expression
Time frame: 5 years
Relapse Free Survival (RFS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
Related trials for Oral Epithelial Dysplasia (OED)
Recruiting
Evaluating Treatment Strategies for p53 Mutant Oral Cancer and Oral Cancer Precursors
Oral Epithelial Dysplasia (OED), Oral Squamous Cell Carcinoma (SCC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sasha Stanton, MD, PhD principal investigator
Providence Health & Services
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAN1012 in people with Oral Epithelial Dysplasia (OED), run by Providence Health & Services.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isa Ngirailemesang, RN (503-215-1979, canrsrchstudies@providence.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Post-operative follow-up visit (30 days after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.