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

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study ID
NCT07045805
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gastric Cancer (GC)

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • QL1706 combined with paclitaxel and bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Jul 1, 2025
Start date
Jul 25, 2025
Status verified
Jun 2025
Primary completion
Jul 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: QL1706 combined with paclitaxel and bevacizumab
    QL1706 7.5 or 5 mgmg/kg combined with paclitaxel 150 mg/m2 and bevacizumab 7.5mg/kg, d1, Q3W

Primary Outcome Measure

PFS [ Time Frame: up to 7 months ]

Central Contacts

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