FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors
NCT ID: NCT05395052
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2022-05-31
2023-08-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort A/A2/AA/AA2: FT536 Monotherapy
FT536 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.
FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
IL-2
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
Cohort B/B2/BB/BB2: FT536 + Avelumab
FT536 + avelumab combination therapy in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.
FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Avelumab
Monoclonal antibody
IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Cohort C/C2/CC/CC2: FT536 + Pembrolizumab, Nivolumab, or Atezolizumab
FT536 + pembrolizumab, nivolumab, or atezolizumab in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.
FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Pembrolizumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Nivolumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Atezolizumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Cohort D/D2/DD/DD2: FT536 + Trastuzumab
FT536 + trastuzumab in participants with locally advanced or metastatic documented human epidermal growth factor receptor 2 (HER2+) expressing tumors
FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Trastuzumab
Monoclonal antibody
IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Cohort E/E2/EE/EE2: FT536 + Cetuximab
FT536 + cetuximab in participants with locally advanced or metastatic squamous NSCLC, CRC, or head and neck cancer.
FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Cetuximab
Monoclonal antibody
IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Cohort F/F2/FF/FF2: FT536 + Amivantamab
FT536 + amivantamab in participants with locally advanced or metastatic NSCLC.
FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Amivantamab
Monoclonal antibody
IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Interventions
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FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
IL-2
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
Avelumab
Monoclonal antibody
Pembrolizumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Nivolumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Atezolizumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Trastuzumab
Monoclonal antibody
Cetuximab
Monoclonal antibody
Amivantamab
Monoclonal antibody
IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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)
18 Years
ALL
No
Sponsors
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Fate Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Fate Trial Disclosure
Role: STUDY_DIRECTOR
Fate Therapeutics
Locations
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Honor Health Research Institute
Scottsdale, Arizona, United States
UCLA Division of Hematology-Oncology
Los Angeles, California, United States
Hackensack University Medical Center - John Theurer Cancer Center
Hackensack, New Jersey, United States
Carolina BioOncology Institute
Huntersville, North Carolina, United States
NEXT Oncology
San Antonio, Texas, United States
Countries
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Other Identifiers
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FT536-101
Identifier Type: -
Identifier Source: org_study_id
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