NCT06446388

Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors

A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 and/or QL1706 Combination Chemotherapy for the Treatment of CLDN18.2-Positive Advanced Malignant Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	QLS31905	Administered as an intravenous infusion.
DRUG	Oxaliplatin	130 mg/m2, intravenous infusion, D1, up to 8 cycles.
DRUG	Capecitabine	1000 mg/m2, oral, bid, D1-D14
DRUG	Gemcitabine	1000 mg/m2 administered as IV infusion on D1/D8 of each cycle.
DRUG	Cisplatin	25 mg/m2, intravenous infusion, D1/D8, up to 8 cycles.
DRUG	QL1706	5 mg/kg, intravenous infusion,D1
DRUG	Chemotherapy drug	Standard chemotherapy recommended by guidelines.

Timeline

• Start date: 2024-06-30
• Primary completion: 2026-06-30
• Completion: 2027-12-01
• First posted: 2024-06-06
• Last updated: 2024-06-06

Locations

1 site across 1 country: China