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

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Fate Therapeutics

Status and phase

Terminated
Phase 1

Conditions

Breast Cancer
Non Small Cell Lung Cancer
GastroEsophageal Cancer
Head and Neck Cancer
Ovarian Cancer
Pancreatic Cancer
Colorectal Cancer

Treatments

Combination Product: Nivolumab
Combination Product: Pembrolizumab
Drug: Fludarabine
Combination Product: Avelumab
Drug: IL-2
Combination Product: Amivantamab
Combination Product: Atezolizumab
Drug: FT536
Combination Product: Cetuximab
Combination Product: Trastuzumab
Drug: Cyclophosphamide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05395052
FT536-101

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

5 participants in 6 patient groups

Cohort A/A2/AA/AA2: FT536 Monotherapy
Experimental group
Description:
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.
Treatment:
Drug: FT536
Drug: Fludarabine
Drug: IL-2
Drug: IL-2
Drug: Cyclophosphamide
Cohort B/B2/BB/BB2: FT536 + Avelumab
Experimental group
Description:
FT536 + avelumab combination therapy in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.
Treatment:
Drug: FT536
Drug: Fludarabine
Drug: IL-2
Drug: IL-2
Drug: Cyclophosphamide
Combination Product: Avelumab
Cohort C/C2/CC/CC2: FT536 + Pembrolizumab, Nivolumab, or Atezolizumab
Experimental group
Description:
FT536 + pembrolizumab, nivolumab, or atezolizumab in participants with locally advanced or metastatic solid tumor indications with documented PD-L1 expression.
Treatment:
Drug: FT536
Combination Product: Atezolizumab
Combination Product: Pembrolizumab
Drug: Fludarabine
Drug: IL-2
Combination Product: Nivolumab
Drug: IL-2
Drug: Cyclophosphamide
Cohort D/D2/DD/DD2: FT536 + Trastuzumab
Experimental group
Description:
FT536 + trastuzumab in participants with locally advanced or metastatic documented human epidermal growth factor receptor 2 (HER2+) expressing tumors
Treatment:
Drug: FT536
Drug: Fludarabine
Combination Product: Trastuzumab
Drug: IL-2
Drug: IL-2
Drug: Cyclophosphamide
Cohort E/E2/EE/EE2: FT536 + Cetuximab
Experimental group
Description:
FT536 + cetuximab in participants with locally advanced or metastatic squamous NSCLC, CRC, or head and neck cancer.
Treatment:
Drug: FT536
Drug: Fludarabine
Drug: IL-2
Combination Product: Cetuximab
Drug: IL-2
Drug: Cyclophosphamide
Cohort F/F2/FF/FF2: FT536 + Amivantamab
Experimental group
Description:
FT536 + amivantamab in participants with locally advanced or metastatic NSCLC.
Treatment:
Combination Product: Amivantamab
Drug: FT536
Drug: Fludarabine
Drug: IL-2
Drug: IL-2
Drug: Cyclophosphamide

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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