This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to evaluate the safety, tolerability, and PK of IGM-7354 in participants with relapsed and/or refractory tumors. The study design consists of a dose-escalation stage and dose-expansion stage. Study participation will consist of a 28-day screening period, a treatment period, and a safety follow-up period 90-days after the last dose.
Patients will be enrolled in two stages: a dose-escalation stage and an expansion stage. The escalation stage will investigate single agent IGM-7354 safety and tolerability in patients with relapsed and/or refractory solid tumors. The dose expansion serial biopsy cohort will assess the intra-tumoral PD changes related to the activity of IGM-7354. IGM-7354 will be administered intravenously (IV).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
IGM-7354 is a PD-L1-targeted cytokine that is designed to regulate T and natural killer cell activation, proliferation and promote their anti-tumor effects
Yale University
New Haven, Connecticut, United States
Florida Cancer Specialists & Research Institute
Sarasota, Florida, United States
Carolina Biooncology Institute
Huntersville, North Carolina, United States
Oklahoma University
Norman, Oklahoma, United States
To evaluate the safety and tolerability of IGM-7354 in participants with cancer including estimation of the MTD or MAD
Incidence of treatment-emergent AEs, SAEs, and DLT per NCI CTCAE v5.0
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Area Under the Curve (AUC) of IGM-7354
Area Under the Curve (AUC) of IGM-7354 as a single agent
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Clearance (CL) of IGM-7354
Clearance (CL) of IGM-7354 as a single agent
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Volume of distribution (V) of IGM-7354
Volume of distribution (V) of IGM-7354 as a single agent
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Maximum Plasma Concentration (Cmax) of IGM-7354
Maximum Plasma Concentration (Cmax) of IGM-7354 as a single agent
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)
Objective Response Rate (ORR)
The ORR is defined as the percentage of participants who achieve a confirmed complete response (CR) or partial response (PR) per RECIST 1.1 as assessed by investigators
Time frame: Study duration of approximately 29 months
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START South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Duration of Response (DoR)
For participants who demonstrate confirmed CR or PR, duration of response is defined as the time from the first documented CR or PR to the first documented disease progression or death, whichever occurs first.
Time frame: Study duration of approximately 29 months
Progression-Free Survival (PFS)
PFS is defined as the time from first dose to the first documented disease progression per RECIST 1.1 by investigator or death, whichever occurs first.
Time frame: Study duration of approximately 29 months
Anti-drug antibodies (ADAs) of IGM-7354
Immunogenicity of IGM-7354
Time frame: At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days)