NCT07315854

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

A Prospective, Single-Center, Exploratory Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy in the Treatment of Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this Phase II clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) combined with SOX chemotherapy (S-1 plus Oxaliplatin) in patients with previously untreated advanced or metastatic gastric cancer or gastroesophageal junction cancer. The main questions it aims to answer are: 1、What is the objective response rate (ORR) of the combination of QL1706 and SOX chemotherapy? 2、What are the safety and tolerability of this combination therapy? Participants will： 1. Receive Iparomlimab and Tuvonralimab (QL1706) via intravenous infusion every 3 weeks. 2. Receive SOX chemotherapy (Oxaliplatin via intravenous infusion on Day 1 and S-1 orally twice daily for 14 days) every 3 weeks for up to 6 cycles. 3. Continue maintenance therapy with QL1706 combined with S-1 after 6 cycles until disease progression or unacceptable toxicity. 4. Undergo tumor imaging assessments (CT or MRI) every 6 weeks for the first 24 weeks, and then every 9 weeks thereafter to monitor the disease.

Detailed description

Study Design: This is a prospective, single-center, single-arm, exploratory Phase II clinical study designed to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706) combined with SOX chemotherapy (S-1 and Oxaliplatin) as a first-line treatment for patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) cancer. The study aims to enroll approximately 32 eligible participants. Intervention and Treatment Regimen: Eligible participants will undergo a screening period of up to 3 weeks. Upon enrollment, subjects will receive the combination therapy in 3-week cycles as follows: Induction Phase (Cycles 1-6): Iparomlimab and Tuvonralimab (QL1706): Administered intravenously at a fixed dose of 5 mg/kg on Day 1 of each cycle. Oxaliplatin: Administered intravenously at a dose of 130 mg/m² on Day 1 of each cycle. S-1 (Tegafur, Gimeracil, Oteracil): Administered orally twice daily (after breakfast and dinner) on Days 1-14, followed by a 7-day rest period. The dose is calculated based on body surface area (BSA): 40 mg/dose for BSA ≤1.25 m²; 50 mg/dose for BSA 1.25-1.5 m²; and 60 mg/dose for BSA \>1.5 m². Maintenance Phase (Cycle 7 onwards): After completing 6 cycles of the combination therapy, patients without disease progression or intolerable toxicity will continue with maintenance therapy consisting of QL1706 (5 mg/kg IV q3w) combined with S-1 (oral, same schedule) until disease progression, death, intolerable toxicity, or withdrawal of consent. Note: Oxaliplatin is discontinued in the maintenance phase. Assessments: Efficacy is assessed using tumor imaging (CT/MRI) according to RECIST v1.1 criteria. Tumor assessments are performed every 6 weeks for the first 24 weeks and every 9 weeks thereafter. The primary endpoint is the Objective Response Rate (ORR). Secondary endpoints include Disease Control Rate (DCR), Progression-Free Survival (PFS), Overall Survival (OS), and 1-year PFS/OS rates. Safety is monitored throughout the study via adverse event reporting (NCI-CTCAE v5.0), laboratory tests, and physical examinations. Follow-up: After treatment discontinuation, patients will enter a safety follow-up period (90 days post-last dose) and a survival follow-up period, where survival status and subsequent anti-tumor therapies will be collected every 2 months.

Conditions

• Gastric Cancer (GC)
• Gastroesophageal Junction Cancer
• Advanced Gastric Cancer
• Metastatic Gastric Cancer

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab (QL1706)	Administered via intravenous (IV) infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle.
DRUG	SOX Chemotherapy	Oxaliplatin: 130mg/m2, iv.gtt, single infusion, 21 days as a cycle, Day 1. Tigio: 40mg (body surface area(BSA)\<1.25m2), 50mg (BSA≥1.25m2, and BAS\<1.5m2), 60mg (BSA ≥1.5m2), p.o, bid, 21 days as a cycle, Day 1-14.

Timeline

• Start date: 2025-11-04
• Primary completion: 2027-12-31
• Completion: 2029-12-31
• First posted: 2026-01-02
• Last updated: 2026-01-06

Locations

1 site across 1 country: China