ClinicaliQ Trial Snapshot
- A Study of Zolbetuximab Together With Pembrolizumab and Chemotherapy in Adults With Gastric Cancer — Recruiting • Phase III • Oncology • NCT06901531.
- What is being tested: Zolbetuximab (a monoclonal antibody targeting claudin-18.2) combined with pembrolizumab (PD-1 inhibitor) and chemotherapy as a treatment for advanced gastric and gastroesophageal junction cancers.
- Patient eligibility overview: Adults with locally advanced or metastatic gastric/GEJ cancer who are treatment-Phase IIIïve, with adequate organ function and performance status; patients must have claudin-18.2 positive tumours.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called gastroesophageal junction (GEJ) cancer. Zolbetuximab with chemotherapy may be used to treat stomach and GEJ cancer when the cancer cells do not have a protein called HER2 (human epidermal growth factor receptor 2) on their surface (HER2-negative) but do have a protein called Claudin 18.2 (Claudin 18.2-positive). Zolbetuximab is thought to work by attaching to the Claudin 18.2 protein in their tumor, which switches on the body's…
Eligibility Snapshot
- : * Participant has histologically confirmed gastric or Gastroesophageal Junction (GEJ) adenocarcinoma. * Participant has radiographically confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to randomization. * Participant has radiologically evaluable disease (measurable and/or nonmeasurable) according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1, ≤ 28 days prior to randomization. For participants with only 1 evaluable lesion and prior radiotherapy ≤ 3 months before randomization, the lesion must either be outside the field of prior radiotherapy or have documented progression following radiation therapy. * Participant has Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0 to 1. * Participant has predicted life expectancy ≥ 12 weeks. * Participant must be a candidate to receive mFOLFOX6 or CAPOX and pembrolizumab. * Female participant is not pregnant and at least 1 of the following conditions apply: * Not a woman of child bearing potential (WOCBP) * WOCBP who has a negative urine or serum pregnancy test at screening (Specific to Japan: with a medical interview), and agrees to follow the contraceptive guidance from the time of informed consent through at least 9 months after the final oxaliplatin administration and 6 months after the final administration of…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.