Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers
NCT ID: NCT04553692
Last Updated: 2025-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
272 participants
INTERVENTIONAL
2020-09-23
2025-01-20
Brief Summary
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Detailed Description
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Colorectal participants may be enrolled in Phase 1b, an open-label, randomized study of aplitabart+FOLFIRI+ bevacizumab.
Aplitabart 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).
Aplitabart will be administered intravenously (IV).
An alternative dosing schedule may be evaluated.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Ph1a: Aplitabart Single Agent Alternate Dosing Escalation
Aplitabart will be administered intravenously as a single agent on an alternate dosing schedule.
Aplitabart (IGM-8444)
DR5 Agonist Investigational Drug
Ph1a: Aplitabart + FOLFIRI ± bevacizumab Escalation and Expansion
Aplitabart will be administered intravenously in combination with FOLFIRI± bevacizumab.
Aplitabart (IGM-8444)
DR5 Agonist Investigational Drug
FOLFIRI
Chemotherapy Regimen
Bevacizumab (and approved biosimilars)
Targeted Therapy
Ph1a: Aplitabart + Birinapant Escalation and Expansion
Aplitabart will be administered intravenously in combination with Birinapant which will also be administered intravenously.
Aplitabart (IGM-8444)
DR5 Agonist Investigational Drug
Birinapant
SMAC-mimetic Investigational Drug
Ph1a: Aplitabart + Venetoclax Escalation and Expansion
Aplitabart will be administered intravenously in combination with Venetoclax.
Aplitabart (IGM-8444)
DR5 Agonist Investigational Drug
Venetoclax
Targeted Therapy
Ph1a: Aplitabart + Docetaxel + Gemcitabine Escalation and Expansion
Aplitabart will be administered intravenously in combination with Docetaxel and Gemcitabine.
Aplitabart (IGM-8444)
DR5 Agonist Investigational Drug
Gemcitabine
Chemotherapy
Docetaxel
Chemotherapy
Ph1a: Aplitabart + Venetoclax + Azacitidine Escalation and Expansion
Aplitabart will be administered intravenously in combination with Venetoclax and Azacitidine.
Aplitabart (IGM-8444)
DR5 Agonist Investigational Drug
Venetoclax
Targeted Therapy
Azacitidine
Chemotherapy
Ph1b: Aplitabart + FOLFIRI + Bevacizumab
Aplitabart will be administered intravenously in combination with FOLFIRI + bevacizumab
Aplitabart (IGM-8444)
DR5 Agonist Investigational Drug
FOLFIRI
Chemotherapy Regimen
Bevacizumab (and approved biosimilars)
Targeted Therapy
Ph1b: FOLFIRI + Bevacizumab
Standard of Care FOLFIRI + bevacizumab will be administered intravenously
FOLFIRI
Chemotherapy Regimen
Bevacizumab (and approved biosimilars)
Targeted Therapy
Interventions
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Aplitabart (IGM-8444)
DR5 Agonist Investigational Drug
FOLFIRI
Chemotherapy Regimen
Bevacizumab (and approved biosimilars)
Targeted Therapy
Birinapant
SMAC-mimetic Investigational Drug
Venetoclax
Targeted Therapy
Gemcitabine
Chemotherapy
Docetaxel
Chemotherapy
Azacitidine
Chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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, participants must be eligible to receive the chemotherapy or targeted agent.
* Ph1a only: No more than three prior therapeutic regimens.
* Ph1b only: Must be FOLFIRI naïve participants and must have received only 1 prior therapeutic regimen administered for the treatment of cancer in the advanced/metastatic setting - OR - FOLFIRI naïve participants that only received adjuvant therapy who progressed within six months after completing adjuvant therapy, and are confirmed to have locally advanced/metastatic disease
Exclusion Criteria
* 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). Participants 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: Participants who have previously received FOLFIRI treatment in the adjuvant, advanced, or metastatic disease setting
18 Years
ALL
No
Sponsors
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IGM Biosciences, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eric Humke, MD, PhD
Role: STUDY_DIRECTOR
IGM Biosciences
Locations
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Mayo Clinic
Phoenix, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Cancer and Blood Specialty Clinic (CBSC)
Los Alamitos, California, United States
USC Norris
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
UC Irvine Manchester Pavilion
Orange, California, United States
UCSF
San Francisco, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
SCRI at Healthone
Denver, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mayo Clinic
Jacksonville, Florida, United States
FL Cancer Specialists - Lake Mary
Lake Mary, Florida, United States
Memorial Cancer Institute
Pembroke Pines, Florida, United States
Florida Cancer Specialists
Sarasota, Florida, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Ochsner Cancer
Jefferson, Louisiana, United States
Maryland Oncology Hematology, PA - Columbia
Columbia, Maryland, United States
START Midwest
Grand Rapids, Michigan, United States
Minnesota Oncology - Minneapolis Clinic
Minneapolis, Minnesota, United States
Mayo Clinic
Minneapolis, Minnesota, United States
Washington University School of Medicine
St Louis, Missouri, United States
Gabrail Cancer Research
Canton, Ohio, United States
Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Providence Portland Medical Center
Portland, Oregon, United States
SCRI - Tennessee
Nashville, Tennessee, United States
Texas Oncology - Austin
Austin, Texas, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
US Oncology - Dallas
Dallas, Texas, United States
US Oncology- Texas Oncology - Fort Worth
Fort Worth, Texas, United States
The University of Texas, MD Anderson
Houston, Texas, United States
Texas Oncology - San Antonio Northeast
San Antonio, Texas, United States
Texas Oncology - Tyler
Tyler, Texas, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
US Oncology- Virginia Oncology - Norfolk
Norfolk, Virginia, United States
Seattle Cancer Alliance - Fred Hutch
Seattle, Washington, United States
Westmead
Westmead, New South Wales, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Napean Cancer Care
Kingswood, , Australia
Tasman Health
Southport, , Australia
Queen Elizabeth Hospital
Woodville South, , Australia
Institut Bergonié
Bordeaux, , France
Centre Georges Francois Leclerc
Dijon, , France
Saint Louis Hospital
Paris, , France
Institut de Cancérologie de l'Ouest
Saint-Herblain, , France
Gustave Roussy
Villejuif, , France
Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Gachon University Gil Hospital
Gyeonggi-do, Seongnam-si, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, Seongnam-si, South Korea
Asan Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital - Yonsei Cancer Center
Soeul, , South Korea
Vall d'Hebron Institut d'Oncologia
Barcelona, , Spain
Clinica Universidad de Navarra
Madrid, , Spain
Madrid FJD
Madrid, , Spain
Madrid CIOCC - HM Universitario Sanchinnarro
Madrid, , Spain
Countries
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Other Identifiers
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IGM-8444-001
Identifier Type: -
Identifier Source: org_study_id
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