RecruitingPhase 1

CAN1012 in Pre-Malignant DCIS and LCIS

A Phase I/Ib Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Ductal Carcinoma in Situ and Lobular Carcinoma in Situ

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests CAN1012 in adults with DCIS or LCIS. These are abnormal cells that stay inside the breast’s milk ducts or milk-making glands.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults age 18 or older of any sex with DCIS or LCIS found in a breast tissue sample taken with a needle.
  • One abnormal area measuring 1 to 5 cm on breast imaging.
  • The tissue sample shows no cancer growing into nearby tissue. Ultrasound shows no suspicious lymph nodes on the same side.
  • Able to understand and sign the study consent form and follow study instructions.
  • Fully active or able to do light activities, and judged fit for the study by the study team.
  • Blood tests within 72 hours before Day 0 must meet the study’s blood cell, kidney, and liver limits.
  • A negative pregnancy test if able to become pregnant.
  • Participants and partners who could conceive must use effective, non-hormonal birth control during treatment and for 165 days after the last dose.

Who can't join

  • A serious physical or mental health condition that could make the study unsafe or affect study completion or results.
  • Need for daily steroids equal to 10 mg or more of prednisone. Inhaled steroids are allowed.
  • Need for hormonal birth control or certain medicines processed by major liver enzymes called CYPs.
  • An immune system disease that attacks the body and poses a significant risk. Some skin conditions and well-controlled hormone conditions are allowed.
  • Past bone marrow transplant or graft-versus-host disease in the mouth, where donated immune cells attack the body.
  • An active infection needing treatment throughout the body, unless the study doctor allows it; active or uncontrolled hepatitis B or C; HIV with an AIDS-related infection; or a known history of hepatitis B or C infection.
  • A heart tracing test showing a QTc above 480 milliseconds, meaning the heart takes too long to reset between beats.
  • Past inflamed bowel pouches, a pocket of infection in the belly, a blocked bowel, or cancer spread in the belly that still raises the risk of a hole in the bowel.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

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