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CAN1012 in Pre-malignant Oral Dysplasia

NCT07620496 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-06-02

No results posted yet for this study

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)

Interventions

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).

Sponsors & Collaborators

  • CanWell Pharma Inc.

    collaborator INDUSTRY

  • Providence Health & Services

    lead OTHER

Principal Investigators

  • Sasha Stanton, MD, PhD · Providence Health & Services

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2031-07-31
Completion
2033-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620496 on ClinicalTrials.gov