A Phase I/IIa Open Label, Non-Randomized, Multicenter Study of CYNK-101 in Combination With Trastuzumab and Pembrolizumab in Patients With Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Aenocarcinoma
This study will find the maximum tolerated dose (MTD) of CYNK-101 which contains Natural
Killer (NK) cells derived from human placental CD34+ cells and culture-expanded. CYNK-101
will be administered as first-line treatment, following induction therapy consisting of
Pembrolizumab, Trastuzumab and a Fluoropyrimidine / Platinum based Chemotherapy regimen.
Patients are required to undergo a biopsy for confirmation of HER2 positivity defined as
either IHC 3+ or IHC 2+ with a positive fluorescent in-situ hybridization (FISH) or FISH +
alone. The safety of this treatment will be evaluated, and researchers will want to learn if
NK cells will help in treating patients with Locally Advanced Unresectable or Metastatic
HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma.
Metastatic HER2 Positive Gastroesophageal Junction Cancer
Recombinant human interleukin-2,
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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