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Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 and/or QL1706 Combination Chemotherapy for the Treatment of CLDN18.2-Positive Advanced Malignant Solid Tumors
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2024-06-30
Completion Date
2027-12-01
Last Updated
2024-06-06
Healthy Volunteers
No
Conditions
Interventions
QLS31905
Administered as an intravenous infusion.
Oxaliplatin
130 mg/m2, intravenous infusion, D1, up to 8 cycles.
Capecitabine
1000 mg/m2, oral, bid, D1-D14
Gemcitabine
1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
Cisplatin
25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
QL1706
5 mg/kg, intravenous infusion,D1
Chemotherapy drug
Standard chemotherapy recommended by guidelines.
Locations (1)
Beijing Cancer Hospital
Beijing, Beijing Municipality, China