RecruitingPhase 2NCT07315854

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

Sponsor

Beijing Friendship Hospital

Enrollment

32 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Gastric Cancer (GC)

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of immunotherapy drugs (iparomlimab and tuvonralimab, also called QL1706) together with chemotherapy as a first treatment for people with advanced stomach or gastroesophageal junction cancer that is HER2-negative. **You may be eligible if...** - You are 18 to 80 years old - You have confirmed advanced, recurrent, or metastatic stomach or gastroesophageal junction adenocarcinoma - Your cancer is HER2-negative (confirmed by testing) - You have not previously received systemic treatment for advanced disease (or cancer came back more than 6 months after finishing earlier treatment) - You have at least one measurable tumor and are in good physical condition (ECOG 0 or 1) **You may NOT be eligible if...** - You have previously received systemic therapy for metastatic disease - You have active autoimmune disease or serious infections - You have brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIparomlimab and Tuvonralimab (QL1706)

Administered via intravenous (IV) infusion at a dose of 5 mg/kg on Day 1 of each 3-week cycle.

DRUGSOX 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.