Clinical trial NCT05908396: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: Relapsed and/or Refractory
Relapsed/Refractory Multiple Myeloma
CD38
Anti-CD3
Immunotherapy
monoclonal antibodies
bispecific
T-cell engager
Lead sponsor: IGM Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: 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)
timeFrame: From Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
Secondary outcomes:
measure: Area Under the Curve (AUC) of IGM-2644
timeFrame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
measure: Clearance (CL) of IGM-2644
timeFrame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
measure: Maximum Plasma Concentration (Cmax) of IGM-2644
timeFrame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
measure: Half Life (HL) of IGM-2644
timeFrame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
measure: Anti-Drug Antibodies (ADA) Formation
timeFrame: At predefined intervals from Dose 1 through 30 days after the last dose of study treatment, approximately 14 months (each cycle is 21 days)
measure: Objective Response Rate (ORR)
timeFrame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
measure: Duration of Response (DoR)
timeFrame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
measure: Progression Free Survival (PFS)
timeFrame: At predefined intervals from Dose 1 until documented disease progression, total overall study duration approximately 60 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Nashville
country: United States
facility: Tennessee Oncology (SCRI)
state: Tennessee
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: IGM Biosciences
name: Thomas Manley, MD
role: STUDY_DIRECTOR
References: