Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07408856
Eligibility Criteria:
Inclusion Criteria:
1. Tumor types allowed:
1. Clinically-identified oral epithelial dysplasia (OED), or
2. Biopsy-identified DCIS or LCIS comprising a single lesion ≥ 2 cm in size by imaging (mammogram or MRI) without evidence of invasive disease on the biopsy and US negative for enlarged ipsilateral lymph nodes.
2. Age 18 years or above with ability to give informed consent, comply with the protocol, and sign a study-specific consent document.
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 deemed suitable by investigator or designee for requirements of study.
4. Laboratory values within 72 hours of Day 0:
1. WBC ³ 2.0 K/µL, ANC ³ 1.0 K/µL
2. Hgb ≥ 10 g/dL
3. Platelets ³ 100,000 K/µL
4. Creatinine £ 1.5 x ULN
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 (bHCG urine or serum, people of childbearing potential only)
5. 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.
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 a known history of Human Immunodeficiency Virus (HIV). Testing is not required unless mandated by local health authority.
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07408856
Study Brief:
Protocol Section:
NCT07408856