Phase 1a/1b Study of IGM-8444 Alone and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers
a study on Solid Tumor Colorectal Cancer Lymphoma Non-Hodgkin Lymphoma Sarcoma Chondrosarcoma Small Lymphocytic Lymphoma Chronic Lymphocytic Leukemia Leukemia Acute Myeloid Leukemia
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedcompletion around
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, Bevacizumab, Gemcitabine, 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: Must be FOLFIRI naive subjects and must have received only 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
- UCSF
accepting new patients
San Francisco California 94143 United States - UCLA
accepting new patients
Los Angeles California 90404 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
Frequently Asked Questions
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