Non Hodgkin Lymphoma Clinical Trial

Phase I Study of IGM-8444 Alone and in Combination in Subjects With Relapsed, Refractory, or Newly Diagnosed Cancers

Summary

This study is a first-in-human, Phase 1, 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

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Full Description

Patients will be enrolled in 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.

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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

Age ≥ 18 years at time of signing ICF
ECOG Performance Status of 0 or 1
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.
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.
No more than three prior therapeutic regimens

Key Exclusion Criteria:

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

350

Study ID:

NCT04553692

Recruitment Status:

Recruiting

Sponsor:

IGM Biosciences, Inc.

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There are 10 Locations for this study

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City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States More Info
Clinical Trials
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SCRI at Healthone
Denver Colorado, 80218, United States More Info
Clinical Trials
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Yale Cancer Center
New Haven Connecticut, 06510, United States More Info
Clinical Trials
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[email protected]
Florida Cancer Specialists
Sarasota Florida, 34232, United States More Info
Clinical Trials
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Norton Cancer Institute
Louisville Kentucky, 40241, United States More Info
Clinical Trials
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[email protected]
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Clinical Trials
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[email protected]
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Clinical Trials
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[email protected]
SCRI - Tennessee
Nashville Tennessee, 37203, United States More Info
Clinical Trials
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[email protected]
Mary Crowley Cancer Research
Dallas Texas, 75230, United States More Info
Clinical Trials
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[email protected]
The University of Texas, MD Anderson
Houston Texas, 77030, United States More Info
Clinical Trials
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[email protected]

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

350

Study ID:

NCT04553692

Recruitment Status:

Recruiting

Sponsor:


IGM Biosciences, Inc.

How clear is this clinincal trial information?

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