CAN1012 in Pre-Malignant DCIS and LCIS

NCT07408856 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 2025001065
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ductal Carcinoma in Situ; Lobular Carcinoma in Situ

Outcome Measures

Primary Outcomes (1)

• Safety of CAN1012

  Safety will be measured by demonstrating that there is a less than 33% rate of delayed surgery attributable to the study treatment.

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

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 a IFN-a biased, long-acting, highly selective TLR7 agonist, which acts as an immune modulator capable of priming both innate and adaptive immunity against tumors. CAN1012 will be administered as an injection directly into the target lesion prior to surgery.

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:

• Male or female patients with DCIS or LCIS found on core biopsy.
• Tumor types allowed:
• Biopsy-identified DCIS or LCIS comprising a single lesion ≥ 1 cm and ≤ 5 cm in size by imaging (mammogram or MRI or ultrasound (US)) without evidence of invasive disease on the biopsy and US negative for suspicious ipsilateral lymph nodes.
• 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) ≥ 60.
• 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 for people of childbearing potential (bHCG urine or serum)
• Patients and their partners who are capable of conceiving must agree to use effective methods of contraception (non-hormonal only) 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 known history of Hepatitis B (defined as Hepatitis B surface antigen \[HBsAg\] reactive) or known history of Hepatitis C virus (defined as HCV RNA) infection. Testing for Hepatitis B and Hepatitis C is not required unless mandated by local health authority.
• 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 Sites (1)

Providence Portland Cancer Institute - Franz Clinic

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

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: February 3, 2026
• First Posted: February 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2035
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

US (1)