FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors
NCT ID: NCT05069935
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
16 participants
INTERVENTIONAL
2021-10-15
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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Dose Escalation
* Cohort A: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved
* Cohort B: FT538 plus trastuzumab in subjects with advanced documented HER2+ tumors
* Cohort C: FT538 plus cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell carcinoma (HNSCC)
FT538
FT538 is an allogeneic natural killer (NK)-cell immunotherapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Monoclonal antibody - Dose Escalation
either avelumab, trastuzumab or cetuximab
Dose Expansion
* Cohort A, Arm 1: FT538 plus avelumab in subjects with advanced solid tumors malignancies where anti-PD-1/PD-L1 antibodies are approved (except urothelial carcinoma (UC))
* Cohort A, Arm 2: FT538 plus an anti-PD-1 antibody (nivolumab or pembrolizumab) in subjects with solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved (except UC)
* Cohort B, Arm 1: FT538 plus trastuzumab in subjects with HER2+ tumors
* Cohort C, Arm 1: FT538 plus cetuximab in subjects with advanced CRC or HNSCC
Subjects with UC may be enrolled in the randomized expansion cohorts as follows:
* Cohort A, Arm R1: FT538 plus avelumab
* Cohort A, Arm R2: FT538 plus atezolizumab
FT538
FT538 is an allogeneic natural killer (NK)-cell immunotherapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Monoclonal antibody - Dose Expansion
either avelumab, atezolizumab, nivolumab, pembrolizumab, trastuzumab or cetuximab
Interventions
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FT538
FT538 is an allogeneic natural killer (NK)-cell immunotherapy
Cyclophosphamide
Lympho-conditioning agent
Fludarabine
Lympho-conditioning agent
Monoclonal antibody - Dose Escalation
either avelumab, trastuzumab or cetuximab
Monoclonal antibody - Dose Expansion
either avelumab, atezolizumab, nivolumab, pembrolizumab, trastuzumab or cetuximab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cohort A: The following solid tumor malignancies where anti-PD-1/PD-L1 antibodies are approved: cutaneous melanoma, non-small cell/small cell lung cancer, renal cell carcinoma, head and neck squamous cell cancer, microsatellite instability-high/ mismatch repair deficient cancer, gastric cancer, esophageal cancer, cervical cancer, merkel cell carcinoma, endometrial carcinoma, tumor mutation burden-high ≥ 10 mutations/megabase\], cutaneous squamous cell carcinoma, triple-negative breast cancer.
* Cohort B: HER2+ breast cancer that has relapsed or progressed on trastuzumab and progressed on either pertuzumab or HER2-targeting antibody drug conjugate; HER2+ gastric cancer that has relapsed or progressed on trastuzumab-containing therapy; OR any other HER2+ solid tumor having progressed on at least one line of standard-of-care therapy. For any tumor type in this cohort, HER2 status must be documented by a U.S. Food and Administration (FDA) approved test to be ≥2+ IHC or Average HER2 copy number ≥4 signals per cell by in situ hybridization.
* Cohort C: CRC having progressed following prior cetuximab treatment or has KRAS/NRAS mutation; HNSCC having progressed following prior cetuximab.
Capable of giving signed informed consent
Aged \~ 18 years old
Willingness to comply with study procedures and duration
Measurable disease per 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
Exclusion Criteria
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'thas not 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 hep B, Hep C or HIV Live vaccine within 6 weeks prior to start of lympho-conditioning
Known allergy to albumin (human) or 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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Hackensack University Medical Center
Hackensack, New Jersey, United States
Sarah Cannon
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Countries
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Other Identifiers
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FT538-102
Identifier Type: -
Identifier Source: org_study_id
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