This is a first in human, phase 1, multicenter, open-label study to determine the safety and tolerability of IGM-2644 as a single agent in participants with relapsed and/or refractory MM, for whom standard therapy does not exist, has proven to be ineffective or intolerable, or is considered inappropriate. Dose escalation and dose expansion cohorts will be enrolled to evaluate safety, preliminary efficacy, and further define a RP2D. The total length of the study, from screening of the first participant to the end of the study, is expected to be approximately 60 months.
Patients will be enrolled in two stages: a dose-escalation stage and a dose expansion stage. The escalation stage will investigate single agent IGM-2644 safety and tolerability in patients with relapsed and/or refractory multiple myeloma. The dose expansion cohort(s) will further evaluate safety, PK/PD, and preliminary efficacy of the recommended phase 2 dose (RP2D). IGM-2644 will be administered intravenously (IV).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
IGM-2644 is an engineered, bispecific IgM antibody directed against CD3 and CD38. IGM-2644 is designed to bind to CD38 to selectively target and kill myeloma cancer cells through both T-cell dependent cellular toxicity (TDCC) and complement dependent cytotoxicity (CDC) activities.
City of Hope
Duarte, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Tennessee Oncology (SCRI)
Nashville, Tennessee, United States
To evaluate the safety and tolerability of IGM-2644 in participants with multiple myeloma, including estimation of the maximum tolerated dose (MTD) or maximum administered dose (MAD)
Incidence of treatment-emergent AEs, SAEs, and DLT per NCI CTCAE v5.0
Time frame: From Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Area Under the Curve (AUC) of IGM-2644
Area Under the Curve (AUC) of IGM-2644 as a single agent
Time frame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Clearance (CL) of IGM-2644
Clearance (CL) of IGM-2644
Time frame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Maximum Plasma Concentration (Cmax) of IGM-2644
Maximum Plasma Concentration (Cmax) of IGM-2644 as a single agent
Time frame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Half Life (HL) of IGM-2644
Half Life (HL) of IGM-2644 as a single agent
Time frame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Anti-Drug Antibodies (ADA) Formation
To evaluate the immunogenicity of IGM-2644 as a single agent
Time frame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
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Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Objective Response Rate (ORR)
To assess preliminary efficacy of IGM-2644 as a single agent, defined as the percentage of participants who achieve a confirmed complete response (CR), very good partial response (VGPR), or partial response (PR) per the International Myeloma Working Group (IMWG)
Time frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Duration of Response (DoR)
For participants who demonstrate a confirmed complete response (CR), very good partial response (VGPR), or partial response (PR), defined as the time from the first documented response to the first documented disease progression or death, whichever occurs first.
Time frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Progression Free Survival (PFS)
PFS is defined as the time from first dose to the first documented disease progression per IMWG criteria by investigator or death, whichever occurs first.
Time frame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months