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

I

IGM Biosciences

Status and phase

Enrolling
Phase 1

Conditions

Multiple Myeloma

Treatments

Drug: IGM-2644

Study type

Interventional

Funder types

Industry

Identifiers

NCT05908396
IGM-2644-001

Details and patient eligibility

About

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.

Full 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).

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

100 participants in 2 patient groups

IGM-2644 Dose Escalation
Experimental group
Description:
Participants will receive IGM-2644 via intravenous (IV) infusion weekly.
Treatment:
Drug: IGM-2644
IGM-2644 Dose Expansion
Experimental group
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.
Treatment:
Drug: IGM-2644

Trial contacts and locations

5

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Central trial contact

IGM Clinical Trials

Data sourced from clinicaltrials.gov

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