Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03319459 | FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors | PHASE1 | COMPLETED | 44 | — | — | Jan 18, 2018 | Dec 15, 2020 | Nov 22, 2021 | 4 | United States |
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...