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This is a phase 1 study designed to evaluate the safety, tolerability, and antitumor activity of FT825 (also known as ONO-8250) with or without monoclonal antibody therapy following chemotherapy in participants with advanced human epidermal growth factor receptor 2 (HER2)-positive or other advanced solid tumors. The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT825 in indication-specific cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A: FT825 | Experimental | Participants with advanced HER2-expressing solid tumors receive FT825 following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment). |
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| Regimen B: FT825 + Cetuximab | Experimental | Participants with advanced epidermal growth factor receptor (EGFR)-expressing solid tumors receive FT825 in combination with cetuximab following chemotherapy in Cycle 1 (each cycle is approximately 61 days). Based on the safety, tolerability, and radiographically confirmed clinical benefit to treatment in Cycle 1, participants may be considered for an additional treatment cycle (Cycle 2 retreatment). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FT825 | Drug | FT825 will be administered as an intravenous (IV) infusion at planned dose levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose limiting toxicities (DLTs) | The number of participants with DLTs will be reported. | Up to approximately 29 days |
| Number of participants with treatment-emergent adverse events (TEAEs) | The number of participants with TEAEs will be reported. | Up to approximately 2 years |
| Severity of AEs | Severity of AEs will be determined according to appropriate rating scales for the type of event reported. | Up to approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-Assessed Overall Response Rate (ORR) | ORR is the proportion of participants who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST, v.1.1). | Up to approximately 2 years |
| Investigator-Assessed Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fate Trial Disclosure | Contact | 858-875-1800 | FateTrialDisclosure@fatetherapeutics.com |
| Name | Affiliation | Role |
|---|---|---|
| Study Director | Fate Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Recruiting | Gilbert | Arizona | 85234 | United States | |
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| Fludarabine | Drug | Fludarabine will be administered as an IV infusion at planned dose levels. |
|
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| Cyclophosphamide | Drug | Cyclophosphamide will be administered as an IV infusion at planned dose levels. |
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| Bendamustine | Drug | Bendamustine will be administered as an IV infusion at planned dose levels. |
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| Docetaxel | Drug | Docetaxel will be administered as an IV infusion at planned dose levels. |
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| Cisplatin | Drug | Cisplatin will be administered as an IV infusion at planned dose levels. |
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| Cetuximab | Drug | Cetuximab will be administered as an IV infusion at planned dose levels. |
|
DOR is the duration from the first occurrence of a documented objective response of either PR or CR until the time of disease progression, or death from any cause, whichever occurs first, per RECIST, v.1.1. |
| Up to approximately 2 years |
| Progression-Free Survival (PFS) | PFS is the time from first dose of study intervention to disease progression, or to the day of death for any reason, whichever occurs first, per RECIST, v.1.1. | Up to approximately 2 years |
| Overall Survival (OS) | OS defined as the time from first dose of study intervention to death from any cause. | Up to approximately 2 years |
| Plasma Concentration of FT825 | The plasma concentration of FT825 will be determined. | At designated time points up to approximately 56 days |
| University of California San Diego Moores Cancer Center |
| Recruiting |
| La Jolla |
| California |
| 92037 |
| United States |
| Yale New Haven Hospital - Yale Cancer Center | Recruiting | New Haven | Connecticut | 06510 | United States |
| University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
| Karmanos Cancer Institute | Recruiting | Detroit | Michigan | 48201 | United States |
| University of Minnesota Medical School | Recruiting | Minneapolis | Minnesota | 55455 | United States |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
| Oncology Hematology Care Clinial Trials | Recruiting | Cincinnati | Ohio | 45242 | United States |
| Ohio State University - Comprehensive Cancer Center | Recruiting | Columbus | Ohio | 43210 | United States |
| OU Health Stephenson Cancer Center | Recruiting | Oklahoma City | Oklahoma | 73104 | United States |
| Thomas Jefferson University, Sidney Kimmel Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
| Sarah Cannon Research Institute (SCRI) - Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| C024352 | fludarabine |
| C042382 | fludarabine phosphate |
| D003520 | Cyclophosphamide |
| D000069461 | Bendamustine Hydrochloride |
| D000077143 | Docetaxel |
| D002945 | Cisplatin |
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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