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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

INTRODUCTION

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

BRIEF SUMMARY


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.


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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Incidence of dose-limiting toxicities within each dose level cohort

Primary Outcome 1 - Timeframe: 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 - Timeframe: At the end of Cycle 1 (each cycle is 28 days)

CONDITION

  • Solid Tumor
  • Adult

ELIGIBILITY


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: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Jeff Chou, MD

Role: Study Director

Affiliation: Fate Therapeutics

Overall Contact

Name: Jeff Chou, MD

Phone: 858-875-1800

Email: clinical@fatetherapeutics.com

LOCATION

Facility Status Contact
Facility: University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota 55455
United States 		Status: Recruiting Contact: N/A
Facility: Hackensack University Medical Center/John Theurer Cancer Center
Hackensack, New Jersey 07601
United States 		Status: Recruiting Contact: N/A
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States 		Status: Recruiting Contact: N/A

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