Phase IbII Trial of ATG-022 Plus Pembrolizumab With or Without Chemotherapy for Claudin 18.2-Positive, HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

Researchers are evaluating a phase IbII study of ATG-022 plus pembrolizumab with or without chemotherapy in participants who have Claudin 18.2-positive, HER2-negative, PD-L1 positive advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. The study targets adults who have either progressed after prior systemic therapy or who have not received any systemic therapy for their condition. The study aims to assess the combination treatments for this specific cancer type. Participants receive either ATG-022 plus pembrolizumab alone or combined with chemotherapy CAPOX regimen, including capecitabine and oxaliplatin. The ATG-022 and pembrolizumab drugs are given every 21 days as one cycle, while the CAPOX chemotherapy is administered in 3-week cycles for up to 8 cycles. The study begins with the evaluation of ATG-022 plus pembrolizumab alone, and the addition of chemotherapy will start based on clinical data from this initial group. Throughout the study, participants undergo tumor testing, imaging, and clinical evaluations to measure safety and effectiveness. Researchers monitor adverse events, dose-limiting toxicities, and treatment responses for up to 12 months after enrollment. Blood samples are collected to analyze drug concentrations. Participants are closely followed to assess overall response, duration of response, and progression-free survival, ensuring comprehensive safety and treatment effect data collection.

A Phase Ib/II Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaUnresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma