To evaluate CAN1012(Selective TLR7 agonist) when administered by IT injection to subjects with advanced solid tumors who are not candidates for standard therapy.
This is a Phase 1, open-label, first-in-human, single-arm, multicenter, dose escalation study of IT CAN1012 in subjects with advanced solid tumors who are not candidates for standard therapy. Subjects will be enrolled in cohorts of 3 at each dose level using a 3+3 dose escalation design Approach.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
CAN1012 IT injection (once every 4 weeks)
CanWellPharma
Woburn, Massachusetts, United States
RECRUITINGProvidence Cancer Institute
Portland, Oregon, United States
RECRUITINGSafety and Tolerability
Safety and tolerability as determined by assessment of dose limiting toxicities and the maximum tolerated dose or maximal assessed dose per protocol of CAN1012 with cancers.
Time frame: 12 months
Recommended Phase 2 Dose (RP2D)
To determine a recommended phase 2 dose of CAN1012 for further development by evaluating number of patients with treatment-related adverse events as assessed by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
Time frame: 12 months
Maximum Tolerated Dose (MTD)
Determine the maximum tolerated dose by assessing the Incidence of Dose Limiting Toxicities (DLTs), treatment emergent and treatment related adverse events (assessed by CTCAE v5.0).
Time frame: 12 months
PK characterization - Cmax
Maximum observed plasma and tumor concentration of CAN1012 after IT administration.
Time frame: 12 months
PK characterization - tmax
Time to reach maximum plasma and tumor concentration of CAN1012 after IT administration.
Time frame: 12 months
tumor size in injected lesions and non-injected lesions
Changes in tumor size using computed tomography (CT) scan or magnetic resonance imaging (MRI) scan assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Time frame: 12 months
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