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CAN1012 in Pre-malignant Oral Dysplasia

ConditionOral Epithelial Dysplasia (OED)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorProvidence Health & Services

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

WBC ≥ 2.0 K/µL, ANC ≥ 1.0 K/µL

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

36 Participants
are divided into 4 treatment groups
Group A: Arm A: Day 2-3Experimental treatment 1 intervention
Group B: Arm B: Day 5-7Experimental treatment 1 intervention
Group C: Arm C: Day 9-11Experimental treatment 1 intervention
Group D: Arm D: Day 13-15Experimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Providence Health & Services

Lead sponsor

CanWell Pharma Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: