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

NCT05908396 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: IGM-2644-001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 5

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.

Conditions

Multiple Myeloma

Keywords

Relapsed and/or Refractory; Relapsed/Refractory Multiple Myeloma; CD38; Anti-CD3; Immunotherapy; monoclonal antibodies; bispecific; T-cell engager

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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)

• 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

  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

  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

  At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)

Study Arms (2)

IGM-2644 Dose Escalation

EXPERIMENTAL

Participants will receive IGM-2644 via intravenous (IV) infusion weekly.

Drug: IGM-2644

IGM-2644 Dose Expansion

EXPERIMENTAL

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

Interventions

IGM-2644 DRUG

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.

IGM-2644 Dose Escalation; IGM-2644 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IGM Biosciences, Inc.: lead

Study Sites (5)

City of Hope

Duarte, California, 91010, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Tennessee Oncology (SCRI)

Nashville, Tennessee, 37203, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Thomas Manley, MD

  IGM Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 18, 2023
• Study Start: August 29, 2023
• Primary Completion: February 16, 2024
• Study Completion: February 16, 2024
• Last Updated: August 1, 2024

Record last verified: 2023-08

Locations

US (5)