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RECRUITING
NCT07256782
PHASE1/PHASE2

A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

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

Locations (1)

Shanghai East Hospital

Shanghai, China