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

Sponsors

Lead Sponsor: Fate Therapeutics

Source 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
Completion Date August 2037
Primary Completion Date August 2022
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of dose-limiting toxicities within each dose level cohort At the end of Cycle 1 (each cycle is 28 days)
Nature of dose-limiting toxicities within each dose level cohort At the end of Cycle 1 (each cycle is 28 days)
Secondary Outcome
Measure Time Frame
Incidence, nature and severity of adverse events Up to 15 years
Investigator-assessed duration of response (DOR) Up to 15 years
Disease control rate Up to 15 years
Progression Free Survival (PFS) Up to 15 years
Overall Survival (OS) Up to 15 years
Determination of PK of FT516 in peripheral blood Study Days 1, 2, 4, 8, 11, 18, 22, 29
Enrollment 27
Condition
Intervention

Intervention Type: Drug

Intervention Name: FT516

Description: Experimental Interventional Therapy

Arm Group Label: FT516 in combination with avelumab

Intervention Type: Drug

Intervention Name: Avelumab

Description: Monoclonal antibody

Arm Group Label: FT516 in combination with avelumab

Other Name: Bavencio

Intervention Type: Drug

Intervention Name: Cyclophosphamide

Description: Lympho-conditioning agent

Arm Group Label: FT516 in combination with avelumab

Intervention Type: Drug

Intervention Name: Fludarabine

Description: Lympho-conditioning agent

Arm Group Label: FT516 in combination with avelumab

Intervention Type: Drug

Intervention Name: IL-2

Description: Biologic response modifier

Arm Group Label: FT516 in combination with avelumab

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: DeShaun Noakes

Phone: 858-875-1800

Email: [email protected]

Location
Facility: Status:
University of Minnesota Masonic Cancer Center | Minneapolis, Minnesota, 55455, United States Not yet 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
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: FT516 in combination with avelumab

Type: Experimental

Patient Data No
Study Design Info

Intervention Model: Sequential Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov