Skip to main content
. 2020 Apr;32(2):263–270. doi: 10.21147/j.issn.1000-9604.2020.02.13

2. Ongoing clinical trials of targeted therapy.

Title NCT trial No. Drug (s) tested Sample
size
Primary end point Phase
DLT, dose-limiting toxicity; OS, overall survival; AE, adverse events/effect; SAE, serious adverse event; TRAE, treatment emergent adverse event; ECOG, Eastern Cooperative Oncology Group; ORR, objective response rate; PFS, progression-free survival; PD, progressive disease; MTD, maximum tolerated dose; mFOLFOX6 treatment includes oxaliplatin, leucovorin, fluorouracil; CAPOX contains capecitabine and oxaliplatin.
A phase 2, open-label, randomized study to assess the antitumor activity and safety of zolbetuximab (IMAB362) in combination with nab-paclitaxel and gemcitabine (Nab-P+GEM) as first line treatment in subjects with claudin 18.2 (CLDN18.2) positive, metastatic pancreatic adenocarcinoma NCT03816163 Zolbetuximab + nab-paclitaxel + gemcitabine 141 DLT, OS, AEs (SAE, TRAEs), ECOG 2
A phase 2 study of zolbetuximab (IMAB362) as monotherapy or in combination with mFOLFOX6 in subjects with metastatic or locally advanced unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors have high or intermediate claudin (CLDN) 18.2 expression NCT03505320 Zolbetuximab + mFOLFOX6 102 ORR 2
A phase 3, global, multi-left, double-blind, randomized, efficacy study of zolbetuximab plus mFOLFOX6 compared with placebo plus mFOLFOX6 as first-line treatment of subjects with claudin 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma NCT03504397 Zolbetuximab + mFOLFOX6 550 PFS 3
A phase 3, global, multi-left, double-blind, randomized, efficacy study of zolbetuximab (IMAB362) plus CAPOX compared with placebo plus CAPOX as first-line treatment of subjects with claudin (CLDN) 18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma NCT03653507 Zolbetuximab + CAPOX 500 PFS, PD 3
An open label, dose escalating/dose regimen finding clinical study to evaluate the safety, efficacy, and cytokinetics of autologous humanized anti-claudin 18.2 chimeric antigen receptor T cell in advanced solid tumor subjects NCT03874897 CAR-CLDN18.2 T-cells 15 DLT, MTD 1
Clinical study of redirected autologous T cells with a claudin18.2-targeted chimeric antigen receptor in patients with advanced gastric adenocarcinoma and pancreatic adenocarcinoma NCT03159819 CAR-CLDN18.2 T-cells 24 Safety, tolerability
A phase 1 study of LCAR-C182A cells in the treatment of advanced gastric cancer and pancreatic ductal adenocarcinoma NCT03890198 CAR-CLDN18.2 T-cells LCAR-C182C Cells 18 AEs, transgene levels and cell concentration of LCAR-C82 CAR-T Cells, cytokine concentrations 1