NCT07256782

A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 444 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a phase Ib/II, open-label, multi-center, dose-escalation and expansion in Chinese subjects with advanced solid tumors. This study is in design allowing assessment of safety, tolerability, pharmacokinetics and anti-tumor activity of QLC5508 in combination with other anti-cancer agents. The target population of dose escalation part is patients have progressed on or intolerant to available standard therapies, and the dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	QLC5508	2.4 mg/kg and 2.0 mg/kg, Q3W/Q2W,administered as an IV infusion
DRUG	QL1706	5 mg/kg ,Q3W,administered as an IV infusion
DRUG	Cisplatin/ Carboplatin	Cisplatin(75 mg/m2; Q3W) / Carboplatin（AUC 5 mg/mL/min; Q3W）,administered as an IV infusion
DRUG	QL2107	200 mg, Q3W,administered as an IV infusion
DRUG	Paclitaxel	175 mg/m2, Q3W,administered as an IV infusion
DRUG	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
DRUG	Oxaliplatin	30 mg/m2, Q2W,administered as an IV infusion

Timeline

• Start date: 2025-10-24
• Primary completion: 2026-10-01
• Completion: 2028-05-01
• First posted: 2025-12-01
• Last updated: 2025-12-01

Locations

1 site across 1 country: China