Trials / Terminated
TerminatedNCT05395052
FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors
A Phase I, Open-Label, Multicenter Study of FT536 as Monotherapy and in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Fate Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1 dose-finding study of FT536 given in combination with a monoclonal antibody following lymphodepletion in participants with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.
Conditions
- Non Small Cell Lung Cancer
- Colorectal Cancer
- Breast Cancer
- Ovarian Cancer
- Pancreatic Cancer
- Head and Neck Cancer
- GastroEsophageal Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FT536 | FT536 is an allogeneic natural killer (NK)-cell immunotherapy |
| DRUG | Cyclophosphamide | Lympho-conditioning agent |
| DRUG | Fludarabine | Lympho-conditioning agent |
| DRUG | IL-2 | For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD |
| COMBINATION_PRODUCT | Avelumab | Monoclonal antibody |
| COMBINATION_PRODUCT | Pembrolizumab | For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab. |
| COMBINATION_PRODUCT | Nivolumab | For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab. |
| COMBINATION_PRODUCT | Atezolizumab | For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab. |
| COMBINATION_PRODUCT | Trastuzumab | Monoclonal antibody |
| COMBINATION_PRODUCT | Cetuximab | Monoclonal antibody |
| COMBINATION_PRODUCT | Amivantamab | Monoclonal antibody |
| DRUG | IL-2 | For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD |
Timeline
- Start date
- 2022-05-31
- Primary completion
- 2023-08-11
- Completion
- 2023-08-11
- First posted
- 2022-05-27
- Last updated
- 2023-09-21
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05395052. Inclusion in this directory is not an endorsement.