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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• FT536 — DRUG
  FT536 is an allogeneic natural killer (NK)-cell immunotherapy
• Cyclophosphamide — DRUG
  Lympho-conditioning agent
• Fludarabine — DRUG
  Lympho-conditioning agent
• IL-2 — DRUG
  For Cohort AA ONLY: To be combined with FT536 at the MTD or MAD
• Avelumab — COMBINATION_PRODUCT
  Monoclonal antibody
• Pembrolizumab — COMBINATION_PRODUCT
  For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
• Nivolumab — COMBINATION_PRODUCT
  For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
• Atezolizumab — COMBINATION_PRODUCT
  For Cohorts C/CC, the combination product (monoclonal antibody) will be ONE of the following: pembrolizumab, nivolumab, or atezolizumab.
• Trastuzumab — COMBINATION_PRODUCT
  Monoclonal antibody
• Cetuximab — COMBINATION_PRODUCT
  Monoclonal antibody
• Amivantamab — COMBINATION_PRODUCT
  Monoclonal antibody
• IL-2 — DRUG
  For Cohorts BB-FF ONLY: To be combined with FT536 + mAb at the MTD or MAD

Study Details

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.

Key Dates

Start date

May 31, 2022

Status verified

Sep 2023

Primary completion

Aug 11, 2023

Completion

Aug 11, 2023

Study Design

Enrollment

5 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• 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.
• 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.
• 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.
• 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
• 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.
• Experimental: Cohort F/F2/FF/FF2: FT536 + Amivantamab
  FT536 + amivantamab in participants with locally advanced or metastatic NSCLC.

Primary Outcome Measure

Determine the Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to approximately 3 years ]

Locations (5)

Find similar trials in Scottsdale, AZ

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