CAN1012 in Pre-malignant Oral Dysplasia

NCT07620496 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 2026000210
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection.

Conditions

Oral Epithelial Dysplasia (OED)

Outcome Measures

Primary Outcomes (1)

• 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.

  Post-operative follow-up visit (30 days after surgery)

Secondary Outcomes (3)

• Immunologic Monitoring

  5 years

• LINE-1 Expression

  5 years

• Relapse Free Survival (RFS)

  5 years

Study Arms (4)

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.

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.

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.

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.

Drug: CAN1012

Interventions

CAN1012 DRUG

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).

Arm A: Day 2-3; Arm B: Day 5-7; Arm C: Day 9-11; Arm D: Day 13-15

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Providence Health & Services: lead
• CanWell Pharma Inc.: collaborator

Study Officials

• Sasha Stanton, MD, PhD

  Providence Health & Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isa Ngirailemesang, RN

CONTACT

503-215-1979; canrsrchstudies@providence.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: June 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2033
• Last Updated: June 2, 2026

Record last verified: 2026-05