Ductal Carcinoma in SituPhase 1NCT07408856
CAN1012 in Pre-Malignant DCIS and LCIS
A Phase 1 study testing CAN1012 in people with Ductal Carcinoma in Situ and Lobular Carcinoma in Situ, run by Providence Health & Services at 1 site in United States.
Trial summary
This is a Phase I/Ib study evaluating CAN1012 in patients with ductal carcinoma in situ and lobular carcinoma in situ. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ductal Carcinoma in Situ, Lobular Carcinoma in Situ
- What is being tested?
- CAN1012
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Sep 2026to May 2035
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Providence Portland Cancer Institute - Franz Clinic
Portland, Oregon, 97213
Isa Ngirailemesang, RN, 503-215-1979, canrsrchstudies@providence.org
Sasha Stanton, MD, PhD
About this study
Official title: A Phase I/Ib Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Ductal Carcinoma in Situ and Lobular Carcinoma in Situ
This is a Phase I/Ib study evaluating CAN1012 in patients with ductal carcinoma in situ and lobular carcinoma in situ.
Read the detailed description
This is not a dose finding study, and therefore patients may be enrolled to any of the four arms in any order, based on clinical considerations (e.g. OR scheduling). No arm, per specific disease type, may expand beyond the first 3 patients, until 30-day post-op safety evaluation has been completed. Study analysis is planned after a single dose of intralesional CAN1012.
The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection. The study will be stopped early for patient safety according to stopping rules below. The sample size for the study is not based on any statistical assumptions. The number of subjects is based on the number of cohorts tested and the size of each cohort.
The Safety Analysis Set will consist of all subjects who receive at least one dose of study treatment. The Safety Analysis Set will be used for safety analyses.
The Intent-to-treat (ITT) Analysis Set will consist of all subjects who receive at least one dose of study treatment and have at least one post-Baseline assessment of tumor response.
The disposition of subjects will be summarized by presenting the number of subjects enrolled, the number and percentage of subjects in each analysis population, the number for whom the study drug was discontinued with the reasons for discontinuation, and the number of subjects who discontinued participation in the study with the reason(s) for withdrawal.
- Being tested
- CAN1012
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAN1012Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: CAN1012 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-operative follow-up visit (30 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start16 Sep 2026
- Primary completionMay 2030 (estimated)
- Study completionMay 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ductal Carcinoma in SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- CanWell Pharma Inc.
- Responsible party
- Sponsor
- Investigators
- Sasha Stanton, MD, PhD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408856
- Sponsor's protocol ID
- 2025001065
- Status last verified
- Sep 2026
- First submitted
- 3 Feb 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ib Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Ductal Carcinoma in Situ and Lobular Carcinoma in Situ
- ClinicalTrials.gov ID
- NCT07408856
- Acronym / sponsor ID
- 2025001065
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- CanWell Pharma Inc.
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2035 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase I/Ib study evaluating CAN1012 in patients with ductal carcinoma in situ and lobular carcinoma in situ.
Detailed description
This is not a dose finding study, and therefore patients may be enrolled to any of the four arms in any order, based on clinical considerations (e.g. OR scheduling). No arm, per specific disease type, may expand beyond the first 3 patients, until 30-day post-op safety evaluation has been completed. Study analysis is planned after a single dose of intralesional CAN1012.
The primary objective of this trial is to examine the safety of CAN1012 delivered by intralesional injection ahead of planned surgical resection. The study will be stopped early for patient safety according to stopping rules below. The sample size for the study is not based on any statistical assumptions. The number of subjects is based on the number of cohorts tested and the size of each cohort.
The Safety Analysis Set will consist of all subjects who receive at least one dose of study treatment. The Safety Analysis Set will be used for safety analyses.
The Intent-to-treat (ITT) Analysis Set will consist of all subjects who receive at least one dose of study treatment and have at least one post-Baseline assessment of tumor response.
The disposition of subjects will be summarized by presenting the number of subjects enrolled, the number and percentage of subjects in each analysis population, the number for whom the study drug was discontinued with the reasons for discontinuation, and the number of subjects who discontinued participation in the study with the reason(s) for withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: Day 2-3 | Experimental | Drug: CAN1012Injection 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. |
| Arm B: Day 5-7 | Experimental | Drug: CAN1012Injection 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. |
| Arm C: Day 9-11 | Experimental | Drug: CAN1012Injection 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. |
| Arm D: Day 13-15 | Experimental | Drug: CAN1012Injection 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAN1012CAN1012 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. | Drug | Arm A: Day 2-3, Arm B: Day 5-7, Arm C: Day 9-11, Arm D: Day 13-15 |
Primary outcome
Safety of CAN1012
Time frame: Post-operative follow-up visit (30 days after surgery)
Safety will be measured by demonstrating that there is a less than 33% rate of delayed surgery attributable to the study treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sasha Stanton, MD, PhD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CAN1012 in people with Ductal Carcinoma in Situ and Lobular Carcinoma in Situ, run by Providence Health & Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isa Ngirailemesang, RN (503-215-1979, canrsrchstudies@providence.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CAN1012 (time frame: Post-operative follow-up visit (30 days after surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.