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Trial record 2 of 3 for:    ft-538

FT538 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05069935
Recruitment Status : Recruiting
First Posted : October 6, 2021
Last Update Posted : April 15, 2022
Sponsor:
Information provided by (Responsible Party):
Fate Therapeutics

Brief Summary:
This is a Phase 1 dose-finding study of FT538 in combination with monoclonal antibodies.

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Drug: FT538 Drug: Cyclophosphamide Drug: Fludarabine Combination Product: Monoclonal antibody - Dose Escalation Combination Product: Monoclonal antibody - Dose Expansion Phase 1

Detailed Description:
This is a Phase 1 dose-finding study of FT538 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 189 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open-Label, Multicenter Study of FT538 in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors
Actual Study Start Date : October 15, 2021
Estimated Primary Completion Date : September 5, 2023
Estimated Study Completion Date : August 5, 2025


Arm Intervention/treatment
Experimental: 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)
Drug: FT538
FT538 is an allogeneic natural killer (NK)-cell immunotherapy
Other Name: NK Cell Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent
Other Name: Cy

Drug: Fludarabine
Lympho-conditioning agent
Other Name: Flu

Combination Product: Monoclonal antibody - Dose Escalation
either avelumab, trastuzumab or cetuximab
Other Name: mAb

Experimental: 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
Drug: FT538
FT538 is an allogeneic natural killer (NK)-cell immunotherapy
Other Name: NK Cell Therapy

Drug: Cyclophosphamide
Lympho-conditioning agent
Other Name: Cy

Drug: Fludarabine
Lympho-conditioning agent
Other Name: Flu

Combination Product: Monoclonal antibody - Dose Expansion
either avelumab, atezolizumab, nivolumab, pembrolizumab, trastuzumab or cetuximab
Other Name: mAb




Primary Outcome Measures :
  1. Define RP2D [ Time Frame: 1.5 years ]
    To define the RP2D of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab

  2. Incidence, nature, and severity of AEs, with severity determined according to NCI CTCAE, v5.0 [ Time Frame: 5 years ]
    To evaluate the safety and tolerability of FT538 in combination with the following mAbs in subjects with advanced solid tumors: avelumab, trastuzumab, cetuximab, atezolizumab, nivolumab, and pembrolizumab



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects with locally advanced or metastatic disease who have progressed after at least one line of therapy and diagnosis of one of the following by treatment cohort:

  • 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:

Pregnant or breast-feeding women

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05069935


Contacts
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Contact: DeShaun Noakes 858-875-1800 clinical@fatetherapeutics.com
Contact: Karen Albers 858-875-1800 clinical@fatetherapeutics.com

Locations
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United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Chelsea McCabe    551-996-4725      
United States, Tennessee
Sarah Cannon Recruiting
Nashville, Tennessee, United States, 37203
Contact: AskSARAH line    844-482-4812      
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Ly M Nguyen, MPH    713-563-2169    lmnguyen1@mdanderson.org   
Contact: Danxia Ke, MA    (713) 792-4384    dke@mdanderson.org   
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact: Dominique McReynolds, RN    210-580-9516    dmcreynolds@nextoncology.com   
Contact: Cynthia DeLeon    210-580-9500    cdeleon@nextoncology.com   
Sponsors and Collaborators
Fate Therapeutics
Investigators
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Study Director: Brandon Beagle Fate Therapeutics
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Responsible Party: Fate Therapeutics
ClinicalTrials.gov Identifier: NCT05069935    
Other Study ID Numbers: FT538-102
First Posted: October 6, 2021    Key Record Dates
Last Update Posted: April 15, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fate Therapeutics:
anti-PD-1 / PD-L1 antibodies approved
HER2+
Metastatic CRC
Head and Neck Squamous Cell Carcinoma
NK Cells
Urothelial Cancer
Renal Cell Carcinoma
merkel cell carcinoma
non-small cell lung cancer
NSCLC
triple negative breast cancer
immune checkpoint inhibitor
melanoma, renal cell carcinoma, lung cancer,
triple-negative breast cancer,
head and neck squamous cell carcinoma,
urothelial carcinoma (UC),
Merkel cell carcinoma, squamous
hepatocellular carcinoma
gastric cancer, esophageal cancer, endometrial cancer,
Additional relevant MeSH terms:
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Neoplasms
Cyclophosphamide
Fludarabine
Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists