Not Yet RecruitingPhase 1

CAN1012 in Pre-Malignant DCIS and LCIS

United States24 participantsStarted 2026-05

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patients with DCIS or LCIS found on core biopsy.
✓. Tumor types allowed:
✓. 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

✕. 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.
✕. 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.
✕. 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.

Safety of CAN1012

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

NCT IDNCT07408856

SponsorProvidence Health & Services

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-05

Isa Ngirailemesang, RN

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patients with DCIS or LCIS found on core biopsy.
✓. Tumor types allowed:
✓. 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

✕. 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.
✕. 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.
✕. 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.