Description:
This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies in
subjects 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.
Title
- Brief Title: FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
- Official Title: A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
FT516-102
- NCT ID:
NCT04551885
Conditions
Interventions
Drug | Synonyms | Arms |
---|
FT516 | | FT516 in combination with avelumab |
Avelumab | Bavencio | FT516 in combination with avelumab |
Cyclophosphamide | | FT516 in combination with avelumab |
Fludarabine | | FT516 in combination with avelumab |
IL-2 | Proleukin, Aldesleukin | FT516 in combination with avelumab |
Purpose
This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies in
subjects 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.
Trial Arms
Name | Type | Description | Interventions |
---|
FT516 in combination with avelumab | Experimental | | - FT516
- Avelumab
- Cyclophosphamide
- Fludarabine
- IL-2
|
Eligibility Criteria
Inclusion Criteria:
- Locally advanced or metastatic solid tumor malignancies that have relapsed or
progressed after at least one line of therapy and where the following anti-PD-L1 are
approved: avelumab, atezolizumab or durvalumab
- Capable of giving signed informed consent
- Aged ≥ 18 years old
- Willingness to comply with study procedures and duration
- Measurable disease per iRECIST
- Contraceptive use for women and men as defined in the protocol
Exclusion Criteria:
- Pregnant or breast-feeding women
- ECOG performance status ≥ 2
- Evidence of insufficient organ function
- Clinically significant cardiovascular disease
- Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is
shorter or any investigational therapy within 28 days prior to Day 1
- Known active central nervous system (CNS) involvement by malignancy
- Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or
neurodegenerative disease or receipt of medications for these conditions
- Currently receiving or likely to require immunosuppressive therapy
- Known active infections with Hepatitis B, Hepatitis C or HIV
- Live vaccine within 6 weeks prior to start of lympho-conditioning
- Known allergy to albumin (human) or DMSO
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of dose-limiting toxicities within each dose level cohort |
Time Frame: | At the end of Cycle 1 (each cycle is 28 days) |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Incidence, nature and severity of adverse events |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | |
Measure: | Investigator-assessed duration of response (DOR) |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | Duration of the first occurrence of a documented, objective response until the time of disease progression, relapse or death from any cause, whichever occurs first, per iRECIST |
Measure: | Disease control rate |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | Proportion of subjects with Stable Disease more than 6 months, Partial Response or Complete Response, per iRECIST response criteria |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | The time from first dose of lympho-conditioning to disease progression or to the day of death for any reason, whichever occurs first, per iRECIST response criteria. |
Measure: | Overall Survival (OS) |
Time Frame: | Up to 15 years |
Safety Issue: | |
Description: | The time from first dose of lympho-conditioning to death from any cause |
Measure: | Determination of PK of FT516 in peripheral blood |
Time Frame: | Study Days 1, 2, 4, 8, 11, 18, 22, 29 |
Safety Issue: | |
Description: | The pharmacokinetics of FT516 in peripheral blood will be reported as the relative percentage of product (FT516) DNA versus patient DNA (% chimerism) measured from blood samples at the specified time points |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Fate Therapeutics |
Trial Keywords
- PD-L1
- cellular therapy
- NK cells
- urothelial cancer
- renal cell carcinoma
- merkel cell carcinoma
- non-small cell lung cancer
- NSCLC
- triple negative breast cancer
- immune checkpoint inhibitor
Last Updated
March 5, 2021