CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unre… (NCT05207722) | Clinical Trial Compass
TerminatedPhase 1/2
CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma
Stopped: for business reasons
United States1 participantsStarted 2022-04-14
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Be at least 18 years of age on the day of signing informed consent.
✓. Have cytologically or histologically confirmed diagnosis for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-Positive Gastric or Gastroesophageal junction (G/GEJ) adenocarcinoma.
Exclusion criteria
✕. Patients will be required to undergo a biopsy for confirmation of HER2 expression prior to study entry.
✕. Have measurable disease as assessed by the investigator according to RECIST 1.1 \[Eisenhauer EA et al, 200913\].
✕. Have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
✕. Have a life expectancy of ≥ 6 months.
✕. Patients must agree to use a highly effective method of contraception from the start of the study until 1 year after the last dose of lymphodepletion or 4 months from last dose of pembrolizumab, or 6 months from last dose of trastuzumab; whichever comes later.
✕. Have adequate cardiac function, defined as left ventricular ejection fraction \> 45% as determined by MUGA scan or ECHO and QT interval calculated according to the Fridericia method (≤ 470 ms for men and ≤480 ms for women).
What they're measuring
1
Dose-Limiting Toxicity (DLT)
Timeframe: up to 28 days
2
Maximum Tolerated Dose (MTD)
Timeframe: up to 28 days
3
Overall Response Rate (ORR) as determined by the RECIST 1.1 Investigator using RECIST 1.1.