NCT06255912

Clinical Trial for Advanced or Metastatic Pancreatic Cancer

A Phase II Clinical Trial Assessing the Safety, Tolerability, and Pharmacokinetics of LTC004 in Combination With MIL-97 ± Chemotherapy in Patients With Advanced or Metastatic Pancreatic Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II clinical trial assessing the safety, tolerability, and pharmacokinetics of LTC004 in combination with MIL-97 ± chemotherapy in patients with advanced or metastatic pancreatic cancer. This experiment is divided into two parts: the dose increasing stage (stage 1) and the dose expanding stage (stage 2). For those enrolled in the planned expansion phase, the dose should have passed the safety assessment during the dose escalation phase.

Conditions

• Pancreas Cancer

Interventions

Type	Name	Description
DRUG	LTC004 + MIL-97	Dose group 1：MIL97:0.2mg/kg,Day1,Q3W,LTC004:90ug/kg,Day3,Q3W Dose group 2:MIL97:0.2mg/kg,Day1,Q3W,LTC004:180ug/kg,Day3,Q3W Dose group -1:MIL97:0.2mg/kg,Day1,Q3W,LTC004:45ug/kg,Day3,Q3W
DRUG	LTC004 + MIL-97+chemotherapy	LTC004 + MIL-97+chemotherapy

Timeline

• Start date: 2024-03-01
• Primary completion: 2029-03-01
• Completion: 2031-03-01
• First posted: 2024-02-13
• Last updated: 2024-02-23