Phase II Study of Iparomlimab and Tuvonralimab QL1706 Combined With SOX Chemotherapy in Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

What this Trial Is About

Researchers are evaluating the effectiveness and safety of combining Iparomlimab and Tuvonralimab QL1706 with SOX chemotherapy in patients who have not previously been treated for advanced or metastatic gastric cancer or gastroesophageal junction cancer. This Phase II clinical trial aims to measure the objective response rate ORR and assess how well patients tolerate this combination therapy. Participants will first undergo up to 3 weeks of screening before starting treatment. The treatment involves an induction phase of up to 6 cycles each cycle lasting 3 weeks where patients receive Iparomlimab and Tuvonralimab intravenously on Day 1, Oxaliplatin intravenously on Day 1, and oral S-1 twice daily for 14 days followed by a 7-day rest. After 6 cycles, those without disease progression or intolerable side effects will continue maintenance therapy with QL1706 and S-1 until disease advancement or unacceptable toxicity occurs. Throughout the study, tumor imaging using CT or MRI will be done every 6 weeks for the first 24 weeks, then every 9 weeks thereafter to monitor disease status. Safety is tracked through adverse event reporting, lab tests, and physical exams. After treatment ends, patients will have a 90-day safety follow-up and then ongoing survival follow-up every 2 months to collect information on survival and subsequent therapies. The study plans to enroll about 32 participants and may continue until the end of 2029.

Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer