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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
IGM-2644
Sponsored by
IGM Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring Relapsed and/or Refractory, Relapsed/Refractory Multiple Myeloma, CD38, Anti-CD3, Immunotherapy, monoclonal antibodies, bispecific, T-cell engager

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of HopeRecruiting
  • Colorado Blood Cancer InstituteRecruiting
  • Memorial Sloan Kettering Cancer Center
  • Tennessee Oncology (SCRI)Recruiting
  • Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IGM-2644 Dose Escalation

IGM-2644 Dose Expansion

Arm Description

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

Participants will receive IGM-2644 via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Area Under the Curve (AUC) of IGM-2644
Area Under the Curve (AUC) of IGM-2644 as a single agent
Clearance (CL) of IGM-2644
Clearance (CL) of IGM-2644
Maximum Plasma Concentration (Cmax) of IGM-2644
Maximum Plasma Concentration (Cmax) of IGM-2644 as a single agent
Half Life (HL) of IGM-2644
Half Life (HL) of IGM-2644 as a single agent
Anti-Drug Antibodies (ADA) Formation
To evaluate the immunogenicity of IGM-2644 as a single agent
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)
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.
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.

Full Information

First Posted
May 26, 2023
Last Updated
August 11, 2023
Sponsor
IGM Biosciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05908396
Brief Title
Evaluation of IGM-2644 in Adults With Relapsed and/or Refractory Multiple Myeloma
Official Title
An Open-Label, Multicenter, Phase 1 Study of IGM-2644 in Participants With Relapsed and/or Refractory Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
August 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IGM Biosciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Relapsed and/or Refractory, Relapsed/Refractory Multiple Myeloma, CD38, Anti-CD3, Immunotherapy, monoclonal antibodies, bispecific, T-cell engager

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IGM-2644 Dose Escalation
Arm Type
Experimental
Arm Description
Participants will receive IGM-2644 via intravenous (IV) infusion weekly.
Arm Title
IGM-2644 Dose Expansion
Arm Type
Experimental
Arm Description
Participants will receive IGM-2644 via IV infusion at a dose and schedule to be determined after reviewing all available response and safety data.
Intervention Type
Drug
Intervention Name(s)
IGM-2644
Intervention Description
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.
Primary Outcome Measure Information:
Title
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)
Description
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)
Secondary Outcome Measure Information:
Title
Area Under the Curve (AUC) of IGM-2644
Description
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)
Title
Clearance (CL) of IGM-2644
Description
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)
Title
Maximum Plasma Concentration (Cmax) of IGM-2644
Description
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)
Title
Half Life (HL) of IGM-2644
Description
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)
Title
Anti-Drug Antibodies (ADA) Formation
Description
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)
Title
Objective Response Rate (ORR)
Description
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
Title
Duration of Response (DoR)
Description
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
Title
Progression Free Survival (PFS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
IGM Clinical Trials
Phone
(877) 544-6728
Email
clinicaltrials@igmbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Manley, MD
Organizational Affiliation
IGM Biosciences
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IGM Clinical Trials
Phone
877-544-6728
Email
clinicaltrials@igmbio.com
Facility Name
Colorado Blood Cancer Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IGM Clinical Trials
Phone
877-544-6728
Email
clinicaltrials@igmbio.com
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IGM Clinical Trials
Phone
877-544-6728
Email
clinicaltrials@igmbio.com
Facility Name
Tennessee Oncology (SCRI)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IGM Clinical Trials
Phone
877-544-6728
Email
clinicaltrials@igmbio.com
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IGM Clinical Trials
Phone
877-544-6728
Email
clinicaltrials@igmbio.com

12. IPD Sharing Statement

Learn more about this trial

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

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