Ignite Creation Date:
2024-07-17 @ 11:05 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468358
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-05-31
Brief Title:
A Study to Evaluate LB1410 in Combination With LB4330 in Patients With Advanced or Metastatic Solid Tumors
Sponsor:
L L biopharma Co Ltd Shanghai China
Organization:
L L biopharma Co Ltd Shanghai China
Study Overview
Official Title:
A Phase IbII 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:
2024-06
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 IbII open dose-escalation and expansion study of an anti-PD1TIM3 bispecific antibodyLB1410 in combination with an anti-Claudin182IL-10 fusion protein LB4330 in patients with advanced or metastatic solid tumors
Detailed Description:
The phase IbII 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:
None
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?:
None
Is an FDA AA801 Violation?:
None