Table of contents

• Clinical trial overview
• Trials in gastric and gastroesophageal junction cancer
• Trial in pancreatic cancer
• Main endpoints used in the studies
• Who the trials are for
• Study design and comparison groups
• Trial summary table

Clinical trial overview

The clinical trials in this set study Zolbetuximab in people with advanced cancers of the stomach, gastroesophageal junction, and pancreas.^{[1][2][3][4][5][6][7]}

Most studies are interventional, which means the researchers give a treatment and then measure what happens.^{[1][2][3][4][5][6][7]}

The trial phases are mainly Phase 2 and Phase 3, so the program includes both earlier testing and larger confirmatory studies.^{[1][2][3][4][5][6][7]}

Trials in gastric and gastroesophageal junction cancer

Several trials focus on gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma, which is cancer at the point where the esophagus meets the stomach.^[1][4][5][7]

NCT03504397 is a Phase 3 study in people with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, and it compares Zolbetuximab plus mFOLFOX6 with placebo plus mFOLFOX6 as first-line treatment.^[4]

NCT03653507 is another Phase 3 study in the same general disease group, and it compares Zolbetuximab plus CAPOX with placebo plus CAPOX in first-line treatment.^[5]

NCT06901531 is a Phase 3 study that tests Zolbetuximab together with pembrolizumab and chemotherapy, compared with placebo plus pembrolizumab and chemotherapy, in adults with gastric cancer or GEJ adenocarcinoma.^[7]

NCT03505320 is a Phase 2 study in metastatic or locally advanced unresectable gastric or GEJ adenocarcinoma, and it looks at Zolbetuximab as a single treatment and also in combination with chemotherapy and/or immunotherapy.^[1]

Trial in pancreatic cancer

NCT03816163 studies adults with metastatic pancreatic adenocarcinoma, which means pancreatic cancer that has spread to other parts of the body.^[6]

This Phase 2 trial is for people with CLDN18.2-positive disease and looks at Zolbetuximab with nab-paclitaxel and gemcitabine in the first-line setting, meaning it is used as an initial treatment.^[6]

The study includes a safety lead-in phase to confirm the recommended phase 2 dose (RP2D), which is the dose chosen for later testing based on early safety data.^[6]

Main endpoints used in the studies

The trials measure different endpoints, which are the main results the researchers want to study.^{[1][2][3][4][5][6][7]}

One study measures objective response rate (ORR), which is the percentage of patients whose tumors shrink or disappear on imaging or review.^[1]

Several studies measure overall survival (OS), which is the time from the trial start point until death from any cause.^[2][3][6][7]

Other studies measure progression-free survival (PFS), which is the time before the cancer gets worse or the patient dies.^[4][5]

The pancreatic trial also measures safety and tolerability using adverse events, laboratory tests, vital signs, ECGs, and ECOG performance status, which is a simple scale showing how well a person can carry out daily activities.^[6]

Who the trials are for

These studies mainly include adults with advanced disease, such as metastatic cancer or locally advanced unresectable cancer.^{[1][4][5][6][7]}

Many trials require CLDN18.2-positive tumors, which means the cancer has a marker that the study uses to select patients.^{[1][3][4][5][6]}

Some gastric and GEJ trials also require HER2-negative disease, so people with high HER2 levels are not the target group for those studies.^[4][5]

One trial is in second-line treatment, meaning the people had earlier treatment before joining the study, while other studies are in the first-line setting, which means the first treatment used for that cancer.^{[3][4][5][6][7]}

Study design and comparison groups

The trials compare Zolbetuximab with placebo or with standard treatment, so researchers can see whether adding Zolbetuximab changes the results.^[3][4][5][7]

Some studies test Zolbetuximab with chemotherapy such as mFOLFOX6, CAPOX, nab-paclitaxel, gemcitabine, or other regimens listed in the trial data.^{[1][4][5][6][7]}

One Phase 2 study also includes Zolbetuximab with chemotherapy and/or immunotherapy, which means treatment that helps the immune system fight cancer.^[1]

Trial summary table