Clinical trial NCT05395052: FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors
Official title: A Phase I, Open-Label, Multicenter Study of FT536 as Monotherapy and in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Colorectal Cancer
Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Head and Neck Cancer
GastroEsophageal Cancer
Lead sponsor: Fate Therapeutics
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Determine the Recommended Phase 2 Dose (RP2D)
timeFrame: Up to approximately 3 years
measure: Number of Participants with ≥ Adverse Event (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0
timeFrame: Following enrollment completion within dose escalation and expansion, approximately 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: UCLA Division of Hematology-Oncology
state: California
city: Hackensack
country: United States
facility: Hackensack University Medical Center - John Theurer Cancer Center
state: New Jersey
city: Huntersville
country: United States
facility: Carolina BioOncology Institute
state: North Carolina
city: San Antonio
country: United States
facility: NEXT Oncology
state: Texas
Study officials:
affiliation: Fate Therapeutics
name: Fate Trial Disclosure
role: STUDY_DIRECTOR
References: