Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FATE-NK100 · 1 trial · 11 indications
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).
| Arm | Type | Description |
|---|---|---|
| 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 |
|---|---|---|
| FATE-NK100 | DRUG | FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity |
| Cetuximab | DRUG | Epidermal growth factor receptor inhibitor antineoplastic agent |
| Trastuzumab | DRUG | HER2/neu receptor inhibitor |
Inclusion Criteria: 1. Regimen A only (monotherapy): Subjects with advanced metastatic solid tumors 2. Regimen B only (combination with trastuzumab): Subjects with advanced metastatic HER2+ solid tumors 3. Regimen C only (combination with cetuximab): Subjects with advanced metastatic EGFR+ solid tu...
FATE-NK100 is an investigational cell-based cancer therapy developed by Fate Therapeutics, Inc. It was studied as monotherapy and in combination with a monoclonal antibody in patients with advanced solid tumors, including HER2 positive gastric cancer. It is not an approved medicine and remains in clinical development.
FATE-NK100 was studied in HER2 positive gastric cancer as part of a Phase 1 trial in advanced solid tumors. The study evaluated it both alone and combined with a monoclonal antibody. It is investigational and has not been approved for the treatment of gastric cancer or any other indication.
FATE-NK100 is developed by Fate Therapeutics, Inc., a biotechnology company that trades on the Nasdaq under the ticker FATE. The company sponsored the clinical program evaluating the therapy in advanced solid tumors, including HER2 positive gastric cancer.
FATE-NK100 is in Phase 1 development. Its single registered study, NCT03319459, was a Phase 1 trial that has since been completed. The program enrolled 44 participants and has no active trials. FATE-NK100 is investigational and has not received FDA approval.
FATE-NK100 was evaluated in one clinical trial, NCT03319459, titled FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors. The Phase 1 study enrolled 44 participants across sites in the United States and is now completed.
The NCT03319459 trial enrolled adults with advanced solid tumors, including HER2 positive gastric cancer, colorectal cancer, head and neck squamous cell carcinoma, EGFR positive solid tumors, HER2 positive breast cancer, hepatocellular carcinoma, non small cell lung cancer, renal cell carcinoma, pancreatic cancer, and melanoma. Participants were 18 years or older.