FT536 Monotherapy and in Combination With Monoclonal Antibodies in Advanced Solid Tumors

September 19, 2023 updated by: Fate Therapeutics

A Phase I, Open-Label, Multicenter Study of FT536 as Monotherapy and in Combination With Monoclonal Antibodies in Subjects With Advanced Solid Tumors

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Honor Health Research Institute
    • California
      • Los Angeles, California, United States, 90404
        • UCLA Division of Hematology-Oncology
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center - John Theurer Cancer Center
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Carolina BioOncology Institute
    • Texas
      • San Antonio, Texas, United States, 78229
        • NEXT Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Other Names:
  • NK Cell Therapy
Drug: Cyclophosphamide
Lympho-conditioning agent
Other Names:
  • Cy
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Flu
Drug: IL-2
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
Other Names:
  • Interleukin-2
Drug: IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Names:
  • Interleukin-2
Experimental: 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.
Drug: FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Other Names:
  • NK Cell Therapy
Drug: Cyclophosphamide
Lympho-conditioning agent
Other Names:
  • Cy
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Flu
Drug: IL-2
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
Other Names:
  • Interleukin-2
Drug: IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Names:
  • Interleukin-2
Combination product: Avelumab
Monoclonal antibody
Other Names:
  • Bavencio
Experimental: 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.
Drug: FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Other Names:
  • NK Cell Therapy
Drug: Cyclophosphamide
Lympho-conditioning agent
Other Names:
  • Cy
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Flu
Drug: IL-2
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
Other Names:
  • Interleukin-2
Drug: IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Names:
  • Interleukin-2
Combination product: Pembrolizumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Other Names:
  • Keytruda
Combination product: Nivolumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Other Names:
  • Opdivo
Combination product: Atezolizumab
For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
Other Names:
  • Tecentriq
Experimental: 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
Drug: FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Other Names:
  • NK Cell Therapy
Drug: Cyclophosphamide
Lympho-conditioning agent
Other Names:
  • Cy
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Flu
Drug: IL-2
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
Other Names:
  • Interleukin-2
Drug: IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Names:
  • Interleukin-2
Combination product: Trastuzumab
Monoclonal antibody
Other Names:
  • Herceptin
Experimental: Cohort E/E2/EE/EE2: FT536 + Cetuximab
FT536 + cetuximab in participants with locally advanced or metastatic squamous NSCLC, CRC, or head and neck cancer.
Drug: FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Other Names:
  • NK Cell Therapy
Drug: Cyclophosphamide
Lympho-conditioning agent
Other Names:
  • Cy
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Flu
Drug: IL-2
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
Other Names:
  • Interleukin-2
Drug: IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Names:
  • Interleukin-2
Combination product: Cetuximab
Monoclonal antibody
Other Names:
  • Erbitux
Experimental: Cohort F/F2/FF/FF2: FT536 + Amivantamab
FT536 + amivantamab in participants with locally advanced or metastatic NSCLC.
Drug: FT536
FT536 is an allogeneic natural killer (NK)-cell immunotherapy
Other Names:
  • NK Cell Therapy
Drug: Cyclophosphamide
Lympho-conditioning agent
Other Names:
  • Cy
Drug: Fludarabine
Lympho-conditioning agent
Other Names:
  • Flu
Drug: IL-2
For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
Other Names:
  • Interleukin-2
Drug: IL-2
For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD
Other Names:
  • Interleukin-2
Combination product: Amivantamab
Monoclonal antibody
Other Names:
  • Rybrevant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the Recommended Phase 2 Dose (RP2D)
Time Frame: Up to approximately 3 years
The RP2Ds of FT536 monotherapy and FT536 + monoclonal antibody (mAbs) will be determined. The RP2D will be determined based on the overall safety and efficacy profile.
Up to approximately 3 years
Number of Participants with ≥ Adverse Event (AE) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v5.0
Time Frame: Following enrollment completion within dose escalation and expansion, approximately 3 years
The safety and tolerability of FT536 monotherapy and in combination with mAbs will be determined.
Following enrollment completion within dose escalation and expansion, approximately 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fate Therapeutics

Investigators

  • Study Director: Fate Trial Disclosure, Fate Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 31, 2022

Primary Completion (Actual)

August 11, 2023

Study Completion (Actual)

August 11, 2023

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

May 25, 2022

First Posted (Actual)

May 27, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FT536-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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