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CAN1012 in Pre-malignant Oral Dysplasia

27 mei 2026 bijgewerkt door: Providence Health & Services

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

36

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Clinically-identified oral epithelial dysplasia (OED)
  2. Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.

  4. Laboratory values within 72 hours of Day 0:

    1. WBC ≥ 2.0 K/µL, ANC ≥ 1.0 K/µL
    2. Hgb ≥ 10 g/dL
    3. Platelets ≥ 100,000 K/µL
    4. Creatinine Clearance (using Cockcroft-Gault)
    5. AST/ALT ≤ 2.5 x ULN
    6. Total bilirubin ≤ 3 x ULN, (except subjects with Gilbert's Syndrome, who must have a total bilirubin less than 3.0 mg/dL)
    7. Negative pregnancy test (bHCG urine or serum, people of childbearing potential only)
  5. 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.

Exclusion Criteria:

  1. 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.
  2. Need for corticosteroids ≥ 10mg prednisone daily equivalent; inhaled steroids are acceptable.
  3. 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.
  4. 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.
  5. Previous history of bone marrow transplantation or oral Graft Versus Host Disease (GVHD).
  6. Has an active infection requiring systemic therapy. Investigator may allow if deemed not clinically significant.
  7. Has active or uncontrolled Hepatitis B, Hepatitis C, or HIV with AIDS (acquired immunodeficiency syndrome)- defined opportunistic infection.
  8. 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.
  9. 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Arm A: Dag 2-3
Injectie van CAN1012 in de doelziekte zal plaatsvinden op Dag 0. Specimens die tijdens de Standaardzorg (SOC) resectie worden verzameld, zullen worden geëvalueerd op immunologische veranderingen in vergelijking met de baseline op Dagen 2-3.
Geneesmiddel: 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).
Experimenteel: Arm B: Dag 5-7
Injectie van CAN1012 in de doelafwijking vindt plaats op dag 0. Specimens die tijdens de Standaardbehandeling (SOC) resectie worden verzameld, zullen worden geëvalueerd op immunologische veranderingen vergeleken met de uitgangswaarde op dagen 5-7.
Geneesmiddel: 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).
Experimenteel: Arm C: Dag 9-11
Injectie van CAN1012 in de doelafwijking vindt plaats op dag 0. Specimens die tijdens de standaardbehandeling (SOC) resectie worden verzameld, worden geëvalueerd op immunologische veranderingen vergeleken met de uitgangswaarden op dagen 9-11.
Geneesmiddel: 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).
Experimenteel: Arm D: Dag 13-15
Injectie van CAN1012 in de doellaesie zal plaatsvinden op Dag 0. Specimen die tijdens de Standard of Care (SOC)-resectie worden verzameld, zullen worden geëvalueerd op immunologische veranderingen vergeleken met de baseline op Dagen 13-15.
Geneesmiddel: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Safety and Tolerability
Tijdsspanne: 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.
Post-operative follow-up visit (30 days after surgery)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Immunologic Monitoring
Tijdsspanne: 5 years
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.
5 years
LINE-1 Expression
Tijdsspanne: 5 years
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.
5 years
Relapse Free Survival (RFS)
Tijdsspanne: 5 years
Assess whether recurrence of OED or invasive disease (relapse free survival, RFS) within the 5 years of the trial.
5 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Providence Health & Services

Medewerkers

CanWell Pharma Inc.

Onderzoekers

  • Hoofdonderzoeker: Sasha Stanton, MD, PhD, Providence Health & Services

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juli 2026

Primaire voltooiing (Geschat)

1 juli 2031

Studie voltooiing (Geschat)

1 juli 2033

Studieregistratiedata

Eerst ingediend

2 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

27 mei 2026

Eerst geplaatst (Werkelijk)

2 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

2 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

27 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 2026000210

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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