Status:
TERMINATED
FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors
Lead Sponsor:
Fate Therapeutics
Conditions:
Non Small Cell Lung Cancer
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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-esc...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 11 2023
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT05395052
Start Date
May 31 2022
End Date
August 11 2023
Last Update
September 21 2023
Active Locations (5)
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1
Honor Health Research Institute
Scottsdale, Arizona, United States, 85258
2
UCLA Division of Hematology-Oncology
Los Angeles, California, United States, 90404
3
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
4
Carolina BioOncology Institute
Huntersville, North Carolina, United States, 28078