Phase 1 Trial of Hu5F9-G4, a CD47-targeting Antibody
A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies
1 other identifier
interventional
88
1 country
6
Brief Summary
The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2014
Longer than P75 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 12, 2014
CompletedFirst Posted
Study publicly available on registry
August 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedFebruary 5, 2019
February 1, 2019
4.2 years
August 12, 2014
February 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and Tolerability of Hu5F9-G4
The CTCAE criteria will be used to assess adverse events on this trial.
The first 28 days on study, for determination of Dose Limiting Toxicities
Study Arms (1)
Treatment (Hu5F9-G4)
EXPERIMENTALHu5F9-G4 monotherapy
Interventions
Eligibility Criteria
You may qualify if:
- Patients with histologically or cytologically confirmed advanced solid malignancy or Lymphoma
- 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
You may not qualify if:
- Known primary tumors of central nervous system disease
- Known active brain metastases
- Known cardiopulmonary disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (6)
Stanford Cancer Institute
Stanford, California, 94305, United States
University of Chicago
Chicago, Illinois, 60637, United States
START Midwest
Grand Rapids, Michigan, 49503, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
University of Oklahoma
Oklahoma City, Oklahoma, 73104, United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229, United States
Related Publications (2)
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.
PMID: 30811285DERIVEDLiu 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.
PMID: 26390038DERIVED
MeSH Terms
Interventions
Study Officials
- STUDY CHAIR
Chris Takimoto, MD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2014
First Posted
August 15, 2014
Study Start
August 1, 2014
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
February 5, 2019
Record last verified: 2019-02