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A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
QLC5508 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of QLC5508 in combination with other anti-cancer agents in patients with advanced solid tumor patients.
Official title: A Phase Ib/II, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of QLC5508 in Combination With Other Anti-tumor Agents in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
444
Start Date
2025-10-24
Completion Date
2028-05
Last Updated
2025-12-01
Healthy Volunteers
No
Conditions
Interventions
QLC5508
2.4 mg/kg and 2.0 mg/kg, Q3W/Q2W,administered as an IV infusion
QL1706
5 mg/kg ,Q3W,administered as an IV infusion
Cisplatin/ Carboplatin
Cisplatin(75 mg/m2; Q3W) / Carboplatin(AUC 5 mg/mL/min; Q3W),administered as an IV infusion
QL2107
200 mg, Q3W,administered as an IV infusion
Paclitaxel
175 mg/m2, Q3W,administered as an IV infusion
5-fluorouracil (5-FU)
800 mg/m2,Q3W(arm:QLC5508, QL2107 and 5-FU),administered as an IV infusion;1200 mg/m2, Q2W(arm:QLC5508, Oxaliplatin, 5-FU,and leucovorin),administered as an IV infusion
Oxaliplatin
30 mg/m2, Q2W,administered as an IV infusion
Locations (1)
Shanghai East Hospital
Shanghai, China