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 |