Breast Cancer Clinical Trial
FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors
This is a Phase 1 dose-finding study of FT536 monotherapy and in combination with monoclonal antibodies.
This is a Phase 1 dose-finding study of FT536 given in combination with a monoclonal antibody following lymphodepletion 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.
Subjects 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/AA: NSCLC, CRC, BC, ovarian cancer, or pancreatic cancer
Cohorts B/BB and C/CC: Subjects with NSCLC, HNSCC, gastroesophageal adenocarinoma, triple negative breast cancer, or urothelial carcinoma whose tumors express PD-L1 according to defined cutoff
Cohort D/DD: 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/EE: Squamous NSCLC; head and neck cancer that relapsed or progressed following prior cetuximab treatment; CRC subjects who are KRAS/NRAS wild-type are required to have progressed/relapsed on prior cetuximab or panitumumab
Cohort F/FF: 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)
Aged 18 years old or greater
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
Contraceptive use for women and men as defined in the protocol
Pregnant or breast-feeding women
Eastern Cooperative Oncology Group (ECOG) performance status greater than or equal to 2
Evidence of insufficient organ function
Clinically significant cardiovascular disease including left-ventricular ejection fraction < 45%
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 that hasn't remained stable for at least 3 months following effective treatment for CNS disease
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
Active bacterial, fungal, or viral infections including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
Live vaccine within 6 weeks prior to start of lympho-conditioning
Known allergy to albumin (human) or dimethyl sulfoxide (DMSO)
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There are 5 Locations for this study
Scottsdale Arizona, 85258, United States More Info
Los Angeles California, 90404, United States More Info
Hackensack New Jersey, 07601, United States More Info
Huntersville North Carolina, 28078, United States More Info
San Antonio Texas, 78229, United States More Info
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