Evaluation of IGM-2644 in Adults With Relapsed and/or Refractory Multiple Myeloma

Phase 1

Terminated

• Conditions: Multiple Myeloma
• Interventions: Drug: IGM-2644

• Registration Number: NCT05908396
• Lead Sponsor: IGM Biosciences, Inc.

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2023-05-26
• Study First Submitted QC: 2023-06-09
• Study First Posted: 2023-06-18
• Status Verified: 2023-08
• Study Start: 2023-08-29
• Primary Completion: 2024-02-16
• Study Completion: 2024-02-16
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
IGM-2644 Dose Escalation	IGM-2644	Participants will receive IGM-2644 via intravenous (IV) infusion weekly.
IGM-2644 Dose Expansion	IGM-2644	Participants will receive IGM-2644 via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data.

Primary Outcome Measures

Name	Time	Method
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)	From Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)	Incidence of treatment-emergent AEs, SAEs, and DLT per NCI CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
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)	Clearance (CL) of IGM-2644
Anti-Drug Antibodies (ADA) Formation	At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)	To evaluate the immunogenicity of IGM-2644 as a single agent
Area Under the Curve (AUC) 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)	Area Under the Curve (AUC) of IGM-2644 as a single agent
Half Life (HL) 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)	Half Life (HL) of IGM-2644 as a single agent
Maximum Plasma Concentration (Cmax) 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)	Maximum Plasma Concentration (Cmax) of IGM-2644 as a single agent
Objective Response Rate (ORR)	At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months	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)
Progression Free Survival (PFS)	At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months	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.
Duration of Response (DoR)	At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months	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.

Trial Locations

Locations (5)

Colorado Blood Cancer Institute; 🇺🇸 Denver, Colorado, United States

Tennessee Oncology (SCRI); 🇺🇸 Nashville, Tennessee, United States

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States

City of Hope; 🇺🇸 Duarte, California, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States