Clinical Trials /

FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

NCT04551885

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

  • Solid Tumor, Adult

Interventions

DrugSynonymsArms
FT516FT516 in combination with avelumab
AvelumabBavencioFT516 in combination with avelumab
CyclophosphamideFT516 in combination with avelumab
FludarabineFT516 in combination with avelumab
IL-2Proleukin, AldesleukinFT516 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

NameTypeDescriptionInterventions
FT516 in combination with avelumabExperimental
  • 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

September 15, 2020