Back to Clinical Trials

Brief Title: FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

A Phase I, Open-Label, Multicenter Study of FT516 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors


  • Org Study ID: FT516-102
  • Secondary ID: N/A
  • NCT ID: NCT04551885
  • Sponsor: Fate Therapeutics


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.

  • Overall Status
  • Start Date
    September 7, 2020
  • Phase
    Phase 1
  • Study Type


Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A


  • Solid Tumor
  • Adult


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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No


Name: Fate Trial Disclosure

Role: Study Director

Affiliation: Fate Therapeutics

Overall Contact

Name: N/A

Phone: N/A

Email: N/A


Facility Status Contact