Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-30 @ 10:32 AM
Study NCT ID:
NCT06468358
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2024-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors
Sponsor:
L & L Bio Co., Ltd., Ningbo, China
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIGGERCD8
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: