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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COMPLETED
PHASE1
88 participants
INTERVENTIONAL
2014-08-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (Hu5F9-G4)
Hu5F9-G4 monotherapy
Hu5F9-G4
Interventions
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Hu5F9-G4
Eligibility Criteria
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Inclusion Criteria
Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatment.
Adequate hematologic status
Adequate coagulation function
Adequate hepatic function
Adequate renal function
Exclusion Criteria
Known active brain metastases
Known cardiopulmonary disease
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Chris Takimoto, MD
Role: STUDY_CHAIR
Gilead Sciences
Locations
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Stanford Cancer Institute
Stanford, California, United States
University of Chicago
Chicago, Illinois, United States
START Midwest
Grand Rapids, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Oklahoma
Oklahoma City, Oklahoma, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, United States
Countries
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References
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Sikic BI, Lakhani N, Patnaik A, Shah SA, Chandana SR, Rasco D, Colevas AD, O'Rourke T, Narayanan S, Papadopoulos K, Fisher GA, Villalobos V, Prohaska SS, Howard M, Beeram M, Chao MP, Agoram B, Chen JY, Huang J, Axt M, Liu J, Volkmer JP, Majeti R, Weissman IL, Takimoto CH, Supan D, Wakelee HA, Aoki R, Pegram MD, Padda SK. First-in-Human, First-in-Class Phase I Trial of the Anti-CD47 Antibody Hu5F9-G4 in Patients With Advanced Cancers. J Clin Oncol. 2019 Apr 20;37(12):946-953. doi: 10.1200/JCO.18.02018. Epub 2019 Feb 27.
Liu J, Wang L, Zhao F, Tseng S, Narayanan C, Shura L, Willingham S, Howard M, Prohaska S, Volkmer J, Chao M, Weissman IL, Majeti R. Pre-Clinical Development of a Humanized Anti-CD47 Antibody with Anti-Cancer Therapeutic Potential. PLoS One. 2015 Sep 21;10(9):e0137345. doi: 10.1371/journal.pone.0137345. eCollection 2015.
Other Identifiers
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SCI-CD47-001
Identifier Type: -
Identifier Source: org_study_id
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