FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors (NCT04551885) | Clinical Trial Compass
TerminatedPhase 1
FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
Stopped: This study was terminated by the Sponsor.
United States12 participantsStarted 2020-09-07
Plain-language summary
This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Dose-Limiting Toxicities (DLTs) Within Each Dose Level Cohort
Timeframe: Up to Day 29 after the end of Cycle 1 (each cycle is 28 days)
2
Severity of DLTs Within Each Dose Level Cohort
Timeframe: At the end of Cycle 1 (each cycle is 28 days)