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The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.
This is a first-in-human, first-in-class, escalating dose trial of an antibody that inhibits an anti-apoptotic signal in human macrophages. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (Hu5F9-G4) | Experimental | Hu5F9-G4 monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hu5F9-G4 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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
Exclusion Criteria:
Known primary tumors of central nervous system disease
Known active brain metastases
Known cardiopulmonary disease
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| Name | Affiliation | Role |
|---|---|---|
| Chris Takimoto, MD | Gilead Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Stanford | California | 94305 | United States | ||
| University of Chicago |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40318595 | Derived | Cai S, Wei X, Li Q, Jiang Z, Li L. Smart materials in pharmacological drug development: Neutrophils and its constituents for drug delivery and consequent antitumor effects. Mol Immunol. 2025 Jul;183:18-32. doi: 10.1016/j.molimm.2025.04.010. Epub 2025 May 2. | |
| 30811285 | Derived | 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. |
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| ID | Term |
|---|---|
| C000629291 | magrolimab |
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| 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 |
| 26390038 | Derived | 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. |