NCT06468358

A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors

A Phase Ib/II, Open, Dose-escalation and Expansion Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 194 (estimated)
• Sponsor: L & L Bio Co., Ltd., Ningbo, China · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ib/II, open, dose-escalation and expansion study of an anti-PD1/TIM3 bispecific antibody，LB1410 in combination with an anti-Claudin18.2/IL-10 fusion protein, LB4330 in patients with advanced or metastatic solid tumors.

Detailed description

The phase Ib/II clinical study in Chinese patients with advanced or metastatic solid tumors to evaluate the safety, pharmacokinetic (PK), pharmacodynamic (PD), anti-tumor efficacy, and biomarkers of LB1410 in combination with LB4330. The study will include 2 parts: dose escalation (Phase Ib) and dose expansion (Phase II). Repeated intravenous infusion of LB1410 in combination with LB4330 in patients with metastatic or advanced pancreatic ductal adenocarcinoma, cholangiocarcinoma, colorectal cancer, ovarian, fallopian tube, or primary peritoneal cancer, non-small cell lung cancer, gastric and gastroesophageal junction adenocarcinoma, esophageal squamous cell carcinoma, hepatocellular carcinoma, renal cell carcinoma, cervical squamous cell carcinoma, and endometrial carcinoma.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	LB1410	anti-PD-1/TIM3 bispecific antibody
DRUG	LB4330	anti-claudin18.2/IL-10 fusion protein

Timeline

• Start date: 2024-06-19
• Primary completion: 2026-12-30
• Completion: 2027-12-30
• First posted: 2024-06-21
• Last updated: 2025-09-11

Locations

1 site across 1 country: China