NCT07045805

Phase II Study of QL1706 Combined With Paclitaxel and Bevacizumab for Second-Line Immune Rechallenge in Gastric Cancer

Phase II Study of Iparomlimab and Tuvonralimab Combined With Paclitaxel and Bevacizumab for the Treatment of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma That Failed First-Line Treatment With PD-(L)1 Inhibitor Combined With Chemotherapy

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the efficacy and safety of the QL1706 combination with paclitaxel and bevacizumab in patients with gastric adenocarcinoma and gastroesophageal junction adenocarcinoma who have failed first-line standard therapy.

Conditions

• Gastric Cancer (GC)

Interventions

Type	Name	Description
DRUG	QL1706 combined with paclitaxel and bevacizumab	Phase 1: Plan to enroll 6 subjects to receive QL1706 7.5 mg/kg, paclitaxel 150 mg/m², and bevacizumab 7.5 mg/kg, d1, Q3W. Subjects will undergo a 3-week Dose-Limiting Toxicity (DLT) evaluation period. If ≥2 DLTs occur among the 6 subjects, QL1706 5 mg/kg will be selected as the Recommended Phase 2 Dose (RP2D) for Phase 2. Otherwise, QL1706 7.5 mg/kg will be the RP2D for Phase 2. Phase 2: Plan to enroll 54-60 subjects. Starting from Cycle 1, QL1706 will be administered intravenously at the RP2D determined in Phase 1. Subjects will receive: QL1706 (RP2D) Paclitaxel 150 mg/m² Bevacizumab 7.5 mg/kg All agents administered on day 1 of each Q3W cycle. Treatment Duration for All Subjects: Continues until disease progression, intolerable toxicity, withdrawal of informed consent, death, or initiation of new antitumor therapy-whichever occurs first.

Timeline

• Start date: 2025-07-25
• Primary completion: 2027-07-31
• Completion: 2028-03-31
• First posted: 2025-07-01
• Last updated: 2025-07-01