Non Hodgkin Lymphoma Clinical Trial

Phase 1a/1b 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

View Full Description

Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

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.

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.
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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

430

Study ID:

NCT04553692

Recruitment Status:

Recruiting

Sponsor:

IGM Biosciences, Inc.

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There are 32 Locations for this study

See Locations Near You

City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States More Info
Clinical Trials
Contact
[email protected]
USC Norris
Los Angeles California, 90033, United States More Info
Charlean Ketchens
Contact
323-865-3000
[email protected]
UCLA
Los Angeles California, 90404, United States More Info
Rachel Andres
Contact
310-633-8400
[email protected]
UC Irvine Manchester Pavilion
Orange California, 92868, United States More Info
UCI Chao Family Comprehensive Cancer Center
Contact
877-827-8839
[email protected]
UCSF
San Francisco California, 94143, United States More Info
Rocky Mountain Cancer Centers
Denver Colorado, 80218, United States More Info
Kelly Beland
Contact
303-385-2000
[email protected]
SCRI at Healthone
Denver Colorado, 80218, United States More Info
Clinical Trials
Contact
720-754-2610
[email protected]
Yale Cancer Center
New Haven Connecticut, 06510, United States More Info
Christina Weiss
Contact
203-737-3472
[email protected]
FL Cancer Specialists - Lake Mary
Lake Mary Florida, 32746, United States More Info
Jessica Keville
Contact
407-804-6133
[email protected]
Florida Cancer Specialists
Sarasota Florida, 34232, United States More Info
Carly Taylor
Contact
941-377-9993
[email protected]
Norton Cancer Institute
Louisville Kentucky, 40241, United States More Info
Maryland Oncology Hematology, PA - Columbia
Columbia Maryland, 21044, United States More Info
Teresa Saavedra
Contact
301-933-3216
[email protected]
START Midwest
Grand Rapids Michigan, 49546, United States More Info
Ashley Spagnuolo
Contact
[email protected]
Minnesota Oncology - Minneapolis Clinic
Minneapolis Minnesota, 55404, United States More Info
Nykole Starks
Contact
612-884-6300
[email protected]
Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Dave Timm
Contact
314-215-7337
[email protected]
Gabrail Cancer Research
Canton Ohio, 44718, United States More Info
Carrie Smith
Contact
330-417-8231
[email protected]
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States More Info
Christina Caldwell
Contact
405-271-8001
[email protected]
Providence Portland Medical Center
Portland Oregon, 97213, United States More Info
Clinical Trials
Contact
[email protected]
SCRI - Tennessee
Nashville Tennessee, 37203, United States More Info
Clinical Trials
Contact
[email protected]
Texas Oncology - Austin
Austin Texas, 78705, United States More Info
Jennifer Rowan
Contact
512-421-4100
[email protected]
Mary Crowley Cancer Research
Dallas Texas, 75230, United States More Info
Clinical Trials
Contact
[email protected]
The University of Texas, MD Anderson
Houston Texas, 77030, United States More Info
Bria Battle
Contact
713-792-2376
[email protected]
Texas Oncology - San Antonio Northeast
San Antonio Texas, 78217, United States More Info
Edward Saenz
Contact
[email protected]
Texas Oncology - Tyler
Tyler Texas, 75702, United States More Info
Shelly Maxfield
Contact
903-262-6580
[email protected]
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States More Info
Jose Collantes
Contact
571-472-0625
[email protected]
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States More Info
Carrie Friedman
Contact
571-222-2200
[email protected]
Seattle Cancer Alliance - Fred Hutch
Seattle Washington, 98109, United States More Info
Kaysey Orlowski
Contact
[email protected]
Southern Medical Day Care Centre
Wollongong New South Wales, 2500, Australia More Info
Peter MacCallum Cancer Centre
Melbourne Victoria, 3052, Australia More Info
Jeanne Tie
Contact
+61385595000
[email protected]
Tasman Health
Southport , QLD 4, Australia More Info
Nicole Tasker
Contact
[email protected]
Queen Elizabeth Hospital
Woodville South , 5011, Australia More Info
Pamela Cooper
Contact
+61 (0)8 82226410
[email protected]
Samsung Medical Center
Seoul Gangnam-gu, 06351, Korea, Republic of More Info
Gachon University Gil Hospital
Gyeonggi-do Seongnam-si, 13620, Korea, Republic of More Info
Recruitment Contact
Contact
+82-32-460-3209
[email protected]
Seoul National University Bundang Hospital
Gyeonggi-do Seongnam-si, 13620, Korea, Republic of More Info
Recruitment Contact
Contact
+82-31-787-7039
[email protected]
Asan Medical Center
Seoul , 03080, Korea, Republic of More Info
Clinical Trial Recruitment
Contact
+82-2-3010-3910
[email protected]
Severance Hospital - Yonsei Cancer Center
Soeul , , Korea, Republic of More Info
Clinical Trial Recruitment
Contact
+82-2-2228-8137
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

430

Study ID:

NCT04553692

Recruitment Status:

Recruiting

Sponsor:


IGM Biosciences, Inc.

How clear is this clinincal trial information?

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