NCT06041035

A Study of QLS31905 Combination Chemotherapy as First-Line Treatment in Patients With Advanced Solid Tumors

A Phase IB/II Clinical Study to Assess the Efficacy and Safety of QLS31905 in Combination With Chemotherapy as First-line Treatment in Patients With Claudin 18.2 (CLDN18.2) Positive Advanced Malignant Solid Tumors

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of QLS31905 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	QLS31905	Administered as an intravenous infusion.
DRUG	Nab paclitaxel	125 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
DRUG	Gemcitabine	1000 mg/m2 administered as IV infusion on D1/D8/D15 of each cycle.
DRUG	Oxaliplatin	85 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.
DRUG	Capecitabine	1000 mg/m2, oral, bid, D1-D7,D15-D21, up to 6 cycles.
DRUG	Cisplatin	25 mg/m2, intravenous infusion, D1/D15, up to 6 cycles.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-10-01
• Completion: 2025-10-01
• First posted: 2023-09-18
• Last updated: 2023-09-18

Locations

1 site across 1 country: China