NCT06932068

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

Safety and Efficacy of Iparomlimab and Tuvonralimab (QL1706) Combined With Chemotherapy for the Treatment of HER2-Negative, Low PD-L1 Expressing, Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma: A Phase II Single-Arm Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 77 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is single - arm study to explore the safety and efficacy of iparomlimab and tuvonralimab (QL1706) combined with chemotherapy for treating her2-negative, low PD-L1 expressing, unresectable or metastatic gastric/gastroesophageal junction adenocarcinoma

Conditions

• HER2 Negative
• Low PD-L1 Expressing
• Unresectable or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Iparomlimab and Tuvonralimab (QL1706)	5 mg/kg, ivdrip, Day 1, Q3W, until progressive disease or intolerable toxicity.
DRUG	Oxallplation	130 mg/m2, ivdrip, Day 1, Q3W, for the first 6 cycles.
DRUG	Capectitabine Tablets	1000 mg/m2, po, bid, Days 1-14, Q3W, until progressive disease or intolerable toxicity.

Timeline

• Start date: 2025-03-26
• Primary completion: 2026-10-31
• Completion: 2027-10-31
• First posted: 2025-04-17
• Last updated: 2025-04-17

Locations

1 site across 1 country: China