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

July 30, 2024 updated by: IGM Biosciences, Inc.

An Open-Label, Multicenter, Phase 1 Study of IGM-2644 in Participants With Relapsed and/or Refractory Multiple Myeloma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Tennessee Oncology (SCRI)
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: 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
From Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve (AUC) 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)
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)
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)
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)
Maximum Plasma Concentration (Cmax) 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 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)
Half Life (HL) 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)
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)
Anti-Drug Antibodies (ADA) Formation
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)
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)
Objective Response Rate (ORR)
Time Frame: 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)
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Duration of Response (DoR)
Time Frame: 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.
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Progression Free Survival (PFS)
Time Frame: 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.
At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IGM Biosciences, Inc.

Investigators

  • Study Director: Thomas Manley, MD, IGM Biosciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2023

Primary Completion (Actual)

February 16, 2024

Study Completion (Actual)

February 16, 2024

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 9, 2023

First Posted (Actual)

June 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IGM-2644-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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