NCT03319459

FATE-NK100 as Monotherapy and in Combination With Monoclonal Antibody in Subjects With Advanced Solid Tumors

Completed Phase 1 Last updated 22 November 2021

What this trial tests

Phase 1 trial testing FATE-NK100 in HER2 Positive Gastric Cancer in 44 participants. Completed in 15 December 2020.

Timeline

18 January 2018

Primary endpoint
29 May 2020

15 December 2020

Quick facts

Lead sponsor	Fate Therapeutics
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	18 January 2018
Primary completion	29 May 2020
Estimated completion	15 December 2020
Sites	4 locations across United States

Drugs / interventions tested

• FATE-NK100 — full drug profile →
• Cetuximab (cetuximab) — full drug profile →
• Trastuzumab (trastuzumab) — full drug profile →

Conditions studied

• HER2 Positive Gastric Cancer — all drugs for HER2 Positive Gastric Cancer →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Head and Neck Squamous Cell Carcinoma — all drugs for Head and Neck Squamous Cell Carcinoma →
• EGFR Positive Solid Tumor — all drugs for EGFR Positive Solid Tumor →

Sponsor

Fate Therapeutics — full company profile →

Who can join

18 and older, any sex, with HER2 Positive Gastric Cancer or Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1, single-dose, open-label, dose-escalation study. The study will be conducted in three parts (i.e. regimens) in an outpatient setting as follows:

* Regimen A: FATE-NK100 as a monotherapy in subjects with advanced solid tumor malignancies.
* Regimen B: FATE-NK100 in combination with trastuzumab in subjects with human epidermal growth factor receptor 2 positive (HER2+) advanced breast cancer, HER2+ advanced gastric cancer or other advanced HER2+ solid tumors.
* Regimen C: FATE-NK100 in combination with cetuximab in subjects with advanced colorectal cancer (CRC) or head and neck squamous cell cancer (HNSCC), or other epidermal growth factor receptor 1 positive (EGFR1+) advanced solid tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exploring the NK cell platform for cancer immunotherapy.
   Myers JA, Miller JS. · · 2021 · cited 977× · PMID 32934330 · DOI 10.1038/s41571-020-0426-7
2. NK cell-based cancer immunotherapy: from basic biology to clinical development.
   Liu S, Galat V, Galat Y, Lee YKA, et al · · 2021 · cited 504× · PMID 33407739 · DOI 10.1186/s13045-020-01014-w
3. Influence of the Tumor Microenvironment on NK Cell Function in Solid Tumors.
   Melaiu O, Lucarini V, Cifaldi L, Fruci D. · · 2019 · cited 324× · PMID 32038612 · DOI 10.3389/fimmu.2019.03038
4. Immunobiology and immunotherapy of HCC: spotlight on innate and innate-like immune cells.
   Ruf B, Heinrich B, Greten TF. · · 2021 · cited 247× · PMID 33235387 · DOI 10.1038/s41423-020-00572-w
5. Emerging immunotherapy for HCC: A guide for hepatologists.
   Foerster F, Gairing SJ, Ilyas SI, Galle PR. · · 2022 · cited 185× · PMID 35253934 · DOI 10.1002/hep.32447
6. Hepatocellular Carcinoma Immune Landscape and the Potential of Immunotherapies.
   Giraud J, Chalopin D, Blanc JF, Saleh M. · · 2021 · cited 172× · PMID 33815418 · DOI 10.3389/fimmu.2021.655697
7. If we build it they will come: targeting the immune response to breast cancer.
   Gatti-Mays ME, Balko JM, Gameiro SR, Bear HD, et al · · 2019 · cited 152× · PMID 31700993 · DOI 10.1038/s41523-019-0133-7
8. Inflammatory Mechanisms of HCC Development.
   Refolo MG, Messa C, Guerra V, Carr BI, et al · · 2020 · cited 149× · PMID 32164265 · DOI 10.3390/cancers12030641