CAN1012 for Oral Epithelial Dysplasia and Carcinoma In Situ

Overseen By Isa Ngirailemesang, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Providence Health & Services

Must not be taking: Corticosteroids, Hormonal contraceptives

Disqualifiers: Autoimmune diseases, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase I/Ib study evaluating CAN1012 in patients with oral epithelial dysplasia, ductal carcinoma in situ, and lobular carcinoma in situ.

Who Is on the Research Team?

Sasha Stanton, MD, PhD

Principal Investigator

Providence Health & Services

Are You a Good Fit for This Trial?

Inclusion Criteria

I am very active or have minor symptoms that don't limit my daily activities.

Laboratory values within 72 hours of Day 0: WBC ³ 2.0 K/µL, ANC ³ 1.0 K/µL, Hgb ≥ 10 g/dL, Platelets ³ 100,000 K/µL, Creatinine £ 1.5 x ULN, 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 sexually active and capable of conceiving must agree to use effective methods of contraception (non-hormonal only for DCIS and LCIS patients) during the course of treatment and for 165 days after last dose of CAN1012

My tumor is a specific type of non-invasive oral or breast lesion.

Exclusion Criteria

I use hormonal birth control or take medication affected by liver enzymes.

I need to take 10mg or more of prednisone daily, but inhaled steroids are okay.

I have a history of Hepatitis B or C.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of intralesional CAN1012 ahead of planned surgical resection

1 day

Post-operative follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

1 visit (in-person)

Optional additional treatment

For oral epithelial dysplasia patients, the treating investigator may opt to defer surgery and pursue additional injections

What Are the Treatments Tested in This Trial?

Interventions

• CAN1012

How Is the Trial Designed?

Group I: Arm C: Lobular Carcinoma in Situ Patients Experimental Treatment 1 Intervention

Up to 12 lobular carcinoma in situ patients will be enrolled.

Group II: Arm B: Ductal Carcinoma in Situ Patients Experimental Treatment 1 Intervention

Up to 12 ductal carcinoma in situ patients will be enrolled.

Group III: Arm A: Oral Epithelial Dysplasia Patients Experimental Treatment 1 Intervention

Up to 36 oral epithelial dysplasia patients will be enrolled. For oral epithelial dysplasia patients, treating investigator may opt to defer surgery and pursue additional injections.

Who Is Running the Clinical Trial?

Providence Health & Services

Lead Sponsor

Trials

131

Recruited

827,000+

CanWell Pharma Inc.

Industry Sponsor

Trials

1

Recruited

40+