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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05908396
Other study ID # IGM-2644-001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date August 2023
Est. completion date August 2026

Study information

Verified date August 2023
Source IGM Biosciences, Inc.
Contact IGM Clinical Trials
Phone (877) 544-6728
Email clinicaltrials@igmbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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).


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date August 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adults > 18 years at time of consent - ECOG performance status of 0 or 1 - Relapsed and/or refractory multiple myeloma after = 3 prior lines; Must have failed treatment with an IMiD, PI, and anti-CD38 therapy - Measurable disease per the IMWG response criteria - Adequate marrow and organ function without transfusion or growth factor support within 7 days prior to screening - Willing and able to undergo bone marrow aspirate and biopsy per protocol Exclusion Criteria: - Inability to comply with study and follow-up procedures - History of clinically significant primary amyloidosis, plasma cell leukemia, Waldenstrom macroglobulinemia or myelodysplastic syndrome - Received chemotherapy, biologics, or small molecule therapy within 21 days or 5 half-lives, whichever is shorter - Use of any non-approved or investigational agent = 4 weeks prior to the first dose of study drug. - Received last prior anti-CD38 monoclonal antibody treatment within 28 days before first planned dose of the study drug - Current Grade > 1 toxicity, with the exception of Grade 2 peripheral neuropathy, alopecia, or toxicities from prior anti-tumor therapy that are considered irreversible - Large-field radiotherapy within 28 days prior to Day 1 (radiation to a single site as concurrent therapy is allowed) - Prior autologous stem cell transplant within 180 days prior to Day 1 - Prior allogeneic stem cell transplant

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
IGM-2644
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.

Locations

Country Name City State
United States Colorado Blood Cancer Institute Denver Colorado
United States City of Hope Duarte California
United States Tennessee Oncology (SCRI) Nashville Tennessee
United States Memorial Sloan Kettering Cancer Center New York New York
United States Fred Hutchinson Cancer Research Center Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
IGM Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 From Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Secondary Area Under the Curve (AUC) of IGM-2644 Area Under the Curve (AUC) of IGM-2644 as a single agent At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Secondary Clearance (CL) of IGM-2644 Clearance (CL) of IGM-2644 At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Secondary Maximum Plasma Concentration (Cmax) of IGM-2644 Maximum Plasma Concentration (Cmax) of IGM-2644 as a single agent At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Secondary Half Life (HL) of IGM-2644 Half Life (HL) of IGM-2644 as a single agent At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Secondary Anti-Drug Antibodies (ADA) Formation To evaluate the immunogenicity of IGM-2644 as a single agent At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Secondary 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) At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Secondary 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. At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Secondary 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. At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
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