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.
Overal Status | Start Date | Phase | Study Type |
---|---|---|---|
Recruiting | September 7, 2020 | Phase 1 | Interventional |
Primary Outcome 1 - Measure: Incidence of dose-limiting toxicities within each dose level cohort
Primary Outcome 1 - Time Frame: At the end of Cycle 1 (each cycle is 28 days)
Primary Outcome 2 - Measure: Nature of dose-limiting toxicities within each dose level cohort
Primary Outcome 2 - Time Frame: At the end of Cycle 1 (each cycle is 28 days)
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 durvalumabr/>
- 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
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Gender: All
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Jeff Chou, MD
Role: Study Director
Affiliation: Fate Therapeutics
Name: DeShaun Noakes
Phone: 858-875-1800
Email: clinical@fatetherapeutics.com
Facility | Status | Contact |
---|---|---|
University of Minnesota Masonic Cancer Center Minneapolis, Minnesota 55455 United States |
Recruiting | |
Hackensack University Medical Center/John Theurer Cancer Center Hackensack, New Jersey 07601 United States |
Recruiting | |
MD Anderson Cancer Center Houston, Texas 77030 United States |
Not yet recruiting |