Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSF
Dates
study started
estimated completion

Description

Summary

This study is a first-in-human, Phase 1a/1b, multicenter, open-label study to determine the safety, tolerability, and pharmacokinetics of IGM-8444 as a single agent and in combination in subjects with relapsed and/or refractory solid or hematologic cancers, as well as newly diagnosed cancers, and an open-label, randomized study of IGM-8444+FOLFIRI (± bevacizumab).

Official Title

An Open-label, Multicenter, Phase 1a/1b Study of IGM-8444 as a Single Agent and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers

Details

Patients will be enrolled in Phase 1a, which consists of two stages: a dose-escalation stage and an expansion stage. IGM-8444 will be used as a single agent and in combination with numerous other agents where standard therapeutic regimens do not exist, have proven to be ineffective or intolerable, or are considered inappropriate. Colorectal patients may be enrolled in Phase 1b, an open-label, randomized study of IGM-8444+FOLFIRI (± bevacizumab) IGM-8444 will be investigated in numerous tumor types including all-comers solid tumors, colorectal carcinoma (CRC), sarcoma, non-Hodgkin's lymphoma (NHL), acute myeloid leukemia (AML), and chronic lymphocytic leukemia (CLL). IGM-8444 will be administered intravenously (IV). An alternative dosing schedule may be evaluated.

Keywords

Solid Tumor, Colorectal Cancer, Non Hodgkin Lymphoma, Sarcoma, Chondrosarcoma, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia, Relapsed and/or Refractory, Metastatic Cancer, Advanced Tumors, Hematological cancer, Newly diagnosed, Lymphoma, Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Leucovorin, Gemcitabine, Bevacizumab, Docetaxel, Fluorouracil, Irinotecan, Azacitidine, Venetoclax, IGM-8444, FOLFIRI, Bevacizumab (and approved biosimilars), Birinapant, Ph1a: IGM-8444 Single Agent Alternate Dosing Escalation, Ph1a: IGM-8444 + FOLFIRI ± bevacizumab Escalation and Expansion, Ph1a: IGM-8444 + Birinapant Escalation and Expansion, Ph1a: IGM-8444 + Venetoclax Escalation and Expansion, Ph1a: IGM-8444 + Docetaxel + Gemcitabine Escalation and Expansion, Ph1a: IGM-8444 + Venetoclax + Azacitidine Escalation and Expansion, Ph1b: IGM-8444 + FOLFIRI ± Bevacizumab, Ph1b: FOLFIRI ± Bevacizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥ 18 years at time of signing ICF
  • ECOG Performance Status of 0 or 1
  • Histologic documentation of incurable, locally advanced or metastatic tumor of the type being evaluated in individual cohorts.
  • Adequate hepatic and renal function and adequate bone marrow reserve function
  • For combination cohorts, patients must be eligible to receive the chemotherapy or targeted agent.
  • Ph1a only: No more than three prior therapeutic regimens
  • Ph1b only: FOLFIRI naive subjects that received no more than 1 prior therapeutic regimen administered for the treatment of cancer in the advanced/metastatic setting

You CAN'T join if...

  • Inability to comply with study and follow-up procedures.
  • Prior DR5 agonist therapy.
  • Concomitant use of agents well-known to cause liver toxicity.
  • Concomitant use of anti-cancer agents
  • Palliative radiation to bone metastases within 2 weeks prior to Day 1.
  • Major surgical procedure within 4 weeks prior to Day 1.
  • Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible.
  • Prior use of any chemotherapeutic agent or small molecule inhibitors (SMI) within 2 weeks or 5 half-lives, prior to the first dose of study treatment
  • Treatment with a monoclonal antibody, or any other anticancer agent (including biologic, experimental, or hormonal therapy) investigational or otherwise, that is not chemotherapy or a SMI, within 4 weeks or five half-lives prior to first dose of study treatment.
  • Ph1b: Subjects who have previously received FOLFIRI treatment for advanced or metastatic disease

Locations

  • UC Irvine Manchester Pavilion accepting new patients
    Orange California 92868 United States
  • UCSF accepting new patients
    San Francisco California 94143 United States
  • City of Hope Comprehensive Cancer Center accepting new patients
    Duarte California 91010 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
IGM Biosciences, Inc.
ID
NCT04553692
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 430 study participants
Last Updated