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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IGM-7354 Single-Agent Dose Escalation | Experimental | IGM-7354 will be administered intravenously as a single agent. |
|
| IGM-7354 Single-Agent Dose Expansion Serial Biopsy | Experimental | IGM-7354 will be administered intravenously as a single agent and patients will undergo pre-treatment and on-treatment biopsies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IGM-7354 | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of IGM-7354 | Area Under the Curve (AUC) of IGM-7354 as a single agent | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | IGM Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06520 | United States | ||
| Florida Cancer Specialists & Research Institute |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Clearance (CL) of IGM-7354 as a single agent
| 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 | 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 | 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 | Study duration of approximately 29 months |
| 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. | 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. | Study duration of approximately 29 months |
| Anti-drug antibodies (ADAs) of IGM-7354 | Immunogenicity of IGM-7354 | At pre-defined intervals from Cycle 1 Day 1 through end of treatment at approximately 12 months (each cycle is 28 days) |
| Sarasota |
| Florida |
| 34232 |
| United States |
| Carolina Biooncology Institute | Huntersville | North Carolina | 28078 | United States |
| Oklahoma University | Norman | Oklahoma | 73019 | United States |
| START South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |