In short
Clinical trials are studying Zolbetuximab in several cancers, especially stomach, gastroesophageal junction, and pancreatic cancer. These studies look at how well it works, how safe it is, and whether it helps people live longer or keep their cancer from growing. Most trials focus on patients with CLDN18.2-positive tumors and some studies compare Zolbetuximab with standard treatment.
Key points
- Clinical trials of Zolbetuximab are being done in stomach cancer, gastroesophageal junction cancer, and pancreatic cancer. The studies include both Phase 2 and Phase 3 trials, so they range from early testing to larger comparisons against standard treatment. Most trials focus on people whose tumors are CLDN18.2 positive, and some also require HER2-negative disease. The main goals are to see whether Zolbetuximab helps people live longer, delays cancer growth, or improves tumor response. Several trials also look at safety, tolerability, and the best treatment dose.
Clinical trial overview
The clinical trials in this set study Zolbetuximab in people with advanced cancers of the stomach, gastroesophageal junction, and pancreas.
Most studies are interventional, which means the researchers give a treatment and then measure what happens.
The trial phases are mainly Phase 2 and Phase 3, so the program includes both earlier testing and larger confirmatory studies.
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.
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.
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.
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.
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.
Trial in pancreatic cancer
NCT03816163 studies adults with metastatic pancreatic adenocarcinoma, which means pancreatic cancer that has spread to other parts of the body.
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.
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.
Main endpoints used in the studies
The trials measure different endpoints, which are the main results the researchers want to study.
One study measures objective response rate (ORR), which is the percentage of patients whose tumors shrink or disappear on imaging or review.
Several studies measure overall survival (OS), which is the time from the trial start point until death from any cause.
Other studies measure progression-free survival (PFS), which is the time before the cancer gets worse or the patient dies.
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.
Who the trials are for
These studies mainly include adults with advanced disease, such as metastatic cancer or locally advanced unresectable cancer.
Many trials require CLDN18.2-positive tumors, which means the cancer has a marker that the study uses to select patients.
Some gastric and GEJ trials also require HER2-negative disease, so people with high HER2 levels are not the target group for those studies.
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.
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.
Some studies test Zolbetuximab with chemotherapy such as mFOLFOX6, CAPOX, nab-paclitaxel, gemcitabine, or other regimens listed in the trial data.
One Phase 2 study also includes Zolbetuximab with chemotherapy and/or immunotherapy, which means treatment that helps the immune system fight cancer.
Trial summary table
| Trial ID | Phase | Condition | Status | Enrollment | Main endpoint |
|---|---|---|---|---|---|
| NCT03505320 | Phase 2 | Advanced gastric or GEJ adenocarcinoma | Authorised | 143 | Objective response rate |
| 2024-514879-17-00 | Phase 3 | Gastric cancer with peritoneal metastasis | Authorised | 146 | Overall survival |
| NCT06962137 | Phase 2 | CLDN18.2 positive gastro-esophageal adenocarcinoma | Authorised | 200 | Overall survival |
| NCT03504397 | Phase 3 | CLDN18.2-positive, HER2-negative gastric or GEJ adenocarcinoma | Authorised | 566 | Progression-free survival |
| NCT03653507 | Phase 3 | CLDN18.2-positive, HER2-negative gastric or GEJ adenocarcinoma | Authorised | 507 | Progression-free survival |
| NCT03816163 | Phase 2 | CLDN18.2-positive metastatic pancreatic adenocarcinoma | Authorised | 396 | Safety, dose, and overall survival |
| NCT06901531 | Phase 3 | Gastric cancer or GEJ adenocarcinoma | Authorised | 500 | Overall survival |