CAN1012 injection before surgery for DCIS or LCIS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1/1b trial examines the safety of intralesional CAN1012 given ahead of surgical resection in adults with non-invasive breast lesions (DCIS or LCIS). Participants can join in any of four arms in any order based on clinical needs, with a cap of three patients per disease arm until a 30-day post-op safety check is complete. The study uses a Safety Analysis Set for those who receive at least one dose and an ITT Analysis Set for those with post-baseline assessments. Analyses will be conducted after a single CAN1012 dose, with stopping rules in place to protect patient safety. Follow-up and disposition are summarized by enrollment, treatment discontinuation reasons, and withdrawal details.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patients with DCIS or LCIS found on core biopsy.
2. 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.
3. Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.
5. 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) ≥ 60.
   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 for people of childbearing potential (bHCG urine or serum)
6. 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.

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 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.
9. 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.
10. 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.

Where it's running

• Providence Portland Cancer Institute - Franz Clinic
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Sasha Stanton, MD, PhD — Providence Health & Services
• Study coordinator: Isa Ngirailemesang, RN
• Email: canrsrchstudies@providence.org
• Phone: 503-215-1979

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.