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This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Regimen A | Experimental | FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies. |
|
| Regimen B | Experimental | FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors. |
|
| Regimen C | Experimental | Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FATE-NK100 | Drug | FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) | The incidence of dose-limiting toxicity (DLT) within each dose cohort within the first 28 days after FATE-NK100 administration (ie, Day 1 through Day 29). | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Objective-response rate (ORR) | Objective-response rate (ORR): defined as the proportion of patients who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time on study. | 28 days, 57 days, 113 days, 169 days, 225 days, 281 days, 337 days, and 366 days. |
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Inclusion Criteria:
Exclusion Criteria:
Females of reproductive potential that are pregnant or lactating, and males or females not willing to use a highly effective form of contraception from Screening through the end of the study.
Eastern Cooperative Oncology Group (ECOG) performance status >2.
Evidence of insufficient organ function as determined by the protocol.
Receipt of any biological therapy, chemotherapy, or radiation within 1 week of the Screening Visit and at least 3 weeks prior to Day 1, except for patients receiving maintenance trastuzumab.
Have central nervous system disease (CNS) as follows:
Myocardial infarction (MI) within 6 months of Screening Visit.
Severe asthma.
Currently receiving or likely to require systemic immunosuppressive therapy from Day -7 to Day 29.
Uncontrolled infections.
Presence of any medical or social issues that are likely to interfere with study conduct, or may cause increased risk to subject.
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Chou, MD | Fate Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSD Moores Cancer Center | San Diego | California | 92037 | United States | ||
| University of Minnesota |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28790065 | Background | Cichocki F, Valamehr B, Bjordahl R, Zhang B, Rezner B, Rogers P, Gaidarova S, Moreno S, Tuininga K, Dougherty P, McCullar V, Howard P, Sarhan D, Taras E, Schlums H, Abbot S, Shoemaker D, Bryceson YT, Blazar BR, Wolchko S, Cooley S, Miller JS. GSK3 Inhibition Drives Maturation of NK Cells and Enhances Their Antitumor Activity. Cancer Res. 2017 Oct 15;77(20):5664-5675. doi: 10.1158/0008-5472.CAN-17-0799. Epub 2017 Aug 8. |
| Label | URL |
|---|---|
| GSK 3 inhibition drives maturation of NK cells and enhances their antitumor activity | View source |
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| Cetuximab | Drug | Epidermal growth factor receptor inhibitor antineoplastic agent |
|
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| Trastuzumab | Drug | HER2/neu receptor inhibitor |
|
|
| Pharmacokinetics (PK) of FATE-NK100 |
The PK of FATE-NK100, as assessed by the proportion of lymphocytes in peripheral blood that are of donor/product origin at the specified time points. |
| 0 days, 1 day, 3 days, 5 days, 8 days, 12 days, 15 days, 22 days, 29 days, 43 days, 57 days, 85 days, 113 days |
| Minneapolis |
| Minnesota |
| 55455 |
| United States |
| The Ohio State University James Cancer Hospital | Columbus | Ohio | 43210 | United States |
| Baylor Scott & White Research Institute | Dallas | Texas | 75246 | United States |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D006528 | Carcinoma, Hepatocellular |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D002292 | Carcinoma, Renal Cell |
| D010190 | Pancreatic Neoplasms |
| D008545 | Melanoma |
| D001943 | Breast Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D013274 | Stomach Neoplasms |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D008113 | Liver Neoplasms |
| D008107 | Liver Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001941 | Breast Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| 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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