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Study of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid Tumors
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
The goal of this Phase Ib/II interventional study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of QLC5513 combined with QL1706± platinum in the treatment of patients with advanced or metastatic malignant solid tumors. This study is divided into two phases: Phase Ib is the combined dose escalation phase, where dose escalation of QLC5513 combined with QL1706± platinum is conducted and RP2D is explored; In the Phase II tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLC5513 combined with QL1706± platinum-based treatment in patients with advanced or metastatic malignant solid tumors.
Official title: An Open, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
290
Start Date
2025-12-30
Completion Date
2031-08
Last Updated
2025-12-09
Healthy Volunteers
No
Conditions
Interventions
QLC5513 IV infusion
Participants will receive QLC5513 16 mg/kg intravenously on Days1, Day 8 and Day 15 of 28-day cycles.
QL1706, IV infusion
QL1706 5mg/kg intravenously on Day 1 of 21-day.
platinum, IV infusion
Cisplatin: 75 mg/m ² or carboplatin:AUC=5 mg/mL/min on Day 1 of 21-day.