Phase 1/2Terminated
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
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
- Sponsor
- Celularity Incorporated (Industry)
- Enrollment
- 1 enrolled
- Conditions
- Metastatic HER2 Positive Gastroesophageal Junction Cancer
- Interventions
- CYNK-101; Pembrolizumab; Trastuzumab; Recombinant Human Interleukin-2; Cyclophosphamide; Fludarabine; Mesna
- Ages
- adults, older adults
- Registry
- NCT05207722
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Dose-Limiting Toxicity (DLT)
- Maximum Tolerated Dose (MTD)
- Overall Response Rate (ORR) as determined by the RECIST 1.1 Investigator using RECIST 1.1.
History
Last registry update
Primary completion
Started
Registered