Phase 2 Study of Iparomlimab and Tuvonralimab QL1706 with XELOX Chemotherapy for HER2-Negative, Low PD-L1 Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining two drugs, iparomlimab and tuvonralimab QL1706, with chemotherapy to treat adults with HER2-negative, low PD-L1 expressing, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. This phase II trial focuses on patients whose cancer cannot be removed by surgery or has spread to other parts of the body. The study aims to understand how well this combination works and its safety profile in this specific group of patients. Participants will receive iparomlimab and tuvonralimab at a dose of 5 mgkg by intravenous drip on the first day of each 3-week cycle until disease progression or unacceptable side effects occur. They will also receive XELOX chemotherapy, which includes oxaliplatin given intravenously at 130 mgm2 on day 1 of each 3-week cycle for the first 6 cycles, and capecitabine tablets taken orally twice daily from days 1 to 14 of each cycle. This treatment continues until disease progression or intolerable toxicity. The study is a single-arm trial, meaning all participants receive this combination treatment. During the trial, researchers will monitor participants for progression-free survival over 12 months after the last participant joins, along with overall survival, response rates, duration of response, disease control rate, and safety through adverse event tracking for up to about 2 years. Participants will undergo regular assessments to measure tumor response and side effects. The total study period includes these follow-up evaluations to understand the treatments impact and safety profile comprehensively.

Phase II Trial of Iparomlimab/Tuvonralimab (QL1706) + XELOX in HER2-Negative, Low PD-L1 G/GEJ Adenocarcinoma