NCT07331155

A Phase II Clinical Study of LBL-024 Combination Therapy in Patients With Advanced Solid Tumour[Substudy 03(ESCC)]

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour[Substudy Number 03(ESCC)]

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Nanjing Leads Biolabs Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of LBL-024 in Combination With Other Drugs for the Treatment of Patients With Advanced Solid Tumour.

Detailed description

This trial is an open-label, multicenter, phase II clinical study of LBL-024 in combination with other drugs for the treatment of patients with advanced oesophageal squamous cell carcinoma (ESCC),to evaluate the efficacy and safety of LBL-024 combination therapy. This study will have a safety run-in period in which a small number of subjects will be enrolled to receive LBL-024 combination therapy.After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If safety and tolerability are good, the extension study of combination administration will be continued, the subjects will be continued to be enrolled, and the randomized, open, positive control trial design will be adopted.Subjects who meet the criteria will be randomly assigned to the experimental group and the control group in a ratio of 2: 1. This trial will enroll up to 110 subjects.

Conditions

• Advanced Solid Tumour

Interventions

Type	Name	Description
DRUG	LBL-024 for Injection	Intravenous infusion
DRUG	Cisplatin Injection	Intravenous infusion
DRUG	Paclitaxel Injection	Intravenous infusion
DRUG	Tislelizumab Injection	Intravenous infusion
DRUG	5-Fluorouracil injection	Intravenous infusion
DRUG	Capecitabine tablets	Oral administration

Timeline

• Start date: 2026-02-26
• Primary completion: 2028-12-26
• Completion: 2028-12-26
• First posted: 2026-01-09
• Last updated: 2026-03-09

Locations

7 sites across 1 country: China