Study Stopped
This study was terminated by the Sponsor.
FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors
A Phase I, Open-Label, Multicenter Study of FT536 as Monotherapy and in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
1 other identifier
interventional
5
1 country
5
Brief Summary
This is a Phase 1 dose-finding study of FT536 given in combination with a monoclonal antibody following lymphodepletion 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2022
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2022
CompletedFirst Posted
Study publicly available on registry
May 27, 2022
CompletedStudy Start
First participant enrolled
May 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 11, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 11, 2023
CompletedSeptember 21, 2023
September 1, 2023
1.2 years
May 13, 2022
September 19, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Determine the Recommended Phase 2 Dose (RP2D)
The RP2Ds of FT536 monotherapy and FT536 + monoclonal antibody (mAbs) will be determined. The RP2D will be determined based on the overall safety and efficacy profile.
Up to approximately 3 years
Number of Participants with ≥ Adverse Event (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0
The safety and tolerability of FT536 monotherapy and in combination with mAbs will be determined.
Following enrollment completion within dose escalation and expansion, approximately 3 years
Study Arms (6)
Cohort A/A2/AA/AA2: FT536 Monotherapy
EXPERIMENTALFT536 monotherapy in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC), breast cancer (BC), ovarian cancer, or pancreatic cancer.
Cohort B/B2/BB/BB2: FT536 + Avelumab
EXPERIMENTALFT536 + avelumab combination therapy in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.
Cohort C/C2/CC/CC2: FT536 + Pembrolizumab, Nivolumab, or Atezolizumab
EXPERIMENTALFT536 + pembrolizumab, nivolumab, or atezolizumab in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.
Cohort D/D2/DD/DD2: FT536 + Trastuzumab
EXPERIMENTALFT536 + trastuzumab in participants with locally advanced or metastatic documented human epidermal growth factor receptor 2 (HER2+) expressing tumors
Cohort E/E2/EE/EE2: FT536 + Cetuximab
EXPERIMENTALFT536 + cetuximab in participants with locally advanced or metastatic squamous NSCLC, CRC, or head and neck cancer.
Cohort F/F2/FF/FF2: FT536 + Amivantamab
EXPERIMENTALFT536 + amivantamab in participants with locally advanced or metastatic NSCLC.
Interventions
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Lympho-conditioning agent
Lympho-conditioning agent
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
Monoclonal antibody
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Monoclonal antibody
Monoclonal antibody
Monoclonal antibody
Eligibility Criteria
You may qualify if:
- Participants with locally advanced or metastatic disease who have progressed/relapsed, are refractory, intolerant to or refuse standard therapy approved for their specific tumor type:
- Cohort A/A2/AA/AA2: NSCLC, CRC, BC, ovarian cancer, or pancreatic cancer
- Cohorts B/B2/BB/BB2 and C/C2/CC/CC2: Subjects with NSCLC, HNSCC, gastroesophageal adenocarinoma, triple negative breast cancer, or urothelial carcinoma whose tumors express PD-L1 according to defined cutoff
- Cohort D/D2/DD/DD2: Subjects with advanced solid tumor whose tumor(s) express HER2 defined as: ≥2+ by IHC, Average HER2 copy number ≥4 signals per cell by in situ hybridization or ≥4 copies as determined by next generation sequencing
- Cohort E/E2/EE/EE2: Squamous NSCLC; head and neck cancer that relapsed or progressed following prior cetuximab treatment; CRC subjects who are KRAS/NRAS/BRAF wild-type are required to have progressed/relapsed on prior cetuximab or panitumumab
- Cohort F/F2/FF/FF2: NSCLC known to have at least one of the following: epidermal growth factor receptor (EGFR) driver mutation(s) and have progressed on or were intolerant to at least one prior line of EGFR Tyrosine Kinase Inhibitor (TKI) or were not candidates for or declined TKI; mesenchymal-epithelial transition (MET) exon 14 skipping mutation that has progressed on or intolerant of at least one prior line of MET TKI or were not candidates for or declined TKI; MET amplification defined as MET/CEP7 ratio ≥1.8 by Fluorescence in situ hybridization (FISH)
- Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- For subjects with \>1 measurable lesion by RECIST v1.1 that can be safely accessed, willingness to undergo tumor biopsy
- Agrees to contraceptive use for women and men as defined in the protocol
You may not qualify if:
- Is a pregnant or breast-feeding female
- Has Eastern Cooperative Oncology Group (ECOG) performance status ≥2
- Has evidence of insufficient organ function
- Has clinically significant cardiovascular disease including left-ventricular ejection fraction \< 45%
- Has received any 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
- Has a known active malignancy in the central nervous system (CNS) that hasn't remained stable for at least 3 months following effective treatment for CNS disease
- Has a non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions
- Has had any active malignancy other than those studied in this trial within 2 years of the first dose of study therapy
- Is currently receiving or likely to require immunosuppressive therapy
- Has an active bacterial, fungal, or viral infections including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- Has received a live vaccine within 6 weeks prior to start of lympho-conditioning
- Has a known allergy to albumin (human) or dimethyl sulfoxide (DMSO)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Honor Health Research Institute
Scottsdale, Arizona, 85258, United States
UCLA Division of Hematology-Oncology
Los Angeles, California, 90404, United States
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, 07601, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
NEXT Oncology
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Fate Trial Disclosure
Fate Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2022
First Posted
May 27, 2022
Study Start
May 31, 2022
Primary Completion
August 11, 2023
Study Completion
August 11, 2023
Last Updated
September 21, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share