CAN1012 in Pre-Malignant DCIS and LCIS

Part of paid clinical trials in Portland, Oregon.

Sponsor
Providence Health & Services
Study ID
NCT07408856
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Ductal Carcinoma in Situ
  • Lobular Carcinoma in Situ

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CAN1012 — DRUG
    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 Details

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

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2030
Completion
May 31, 2035

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Day 2-3
    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.
  • Experimental: Arm B: Day 5-7
    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.
  • Experimental: Arm C: Day 9-11
    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.
  • Experimental: Arm D: Day 13-15
    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.

Primary Outcome Measure

Safety of CAN1012 [ Time Frame: Post-operative follow-up visit (30 days after surgery) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Providence Portland Cancer Institute - Franz ClinicPortlandOregon97213
Isa Ngirailemesang, RN
[email protected]
503-215-1979
Sasha Stanton, MD, PhD (PRINCIPAL_INVESTIGATOR)
RaYoung Chung, NP (SUB_INVESTIGATOR)
Alison Conlin, MD (SUB_INVESTIGATOR)
Brendan Curti, MD (SUB_INVESTIGATOR)
Molly Davis, NP (SUB_INVESTIGATOR)
Roxanne Griswold, NP (SUB_INVESTIGATOR)
Amy Hartman, NP (SUB_INVESTIGATOR)
Rom Leidner, MD (SUB_INVESTIGATOR)
Rui Li, MD, PhD (SUB_INVESTIGATOR)
Mary Martel, NP (SUB_INVESTIGATOR)
Jamie Martinez, NP (SUB_INVESTIGATOR)
David Page, MD (SUB_INVESTIGATOR)
Rachel Sanborn, MD (SUB_INVESTIGATOR)
Matthew Taylor, MD (SUB_INVESTIGATOR)
Binbin Zheng, MD (SUB_INVESTIGATOR)

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By research site
Providence Portland Cancer Institute - Franz Clinic· Portland, OR

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