NCT07396090

Study of KRAS-Specific Vaccine in Patients With KRAS-Mutated Solid Tumors

A Clinical Study of Safety, Immunogenicity and Preliminary Efficacy of mKRAS Antigen-Loaded eDCs (CAT-101) Monotherapy or Plus Tislelizumab (Anti-PD-1 mAb) in KRAS-G12C/D/R/V-Mutated Advanced Pancreatic Cancer and Other Solid Tumors

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (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

The purpose of this study is to evaluate the safety, immunogenicity and preliminary efficacy of engineered dendritic cells（eDCs）loaded with mKRAS antigen (CAT-101) alone or in combination with Tislelizumab (anti-PD-1 monoclonal antibody) among participants with KRAS-G12C/D/R/V mutated advanced pancreatic cancer and other solid tumors.

Detailed description

The primary objective of this study is to systematically evaluate the safety profile, immunogenicity, and preliminary clinical efficacy of mKRAS antigen-loaded engineered dendritic cells (eDCs, designated as CAT-101), administered either as monotherapy or in combination with Tislelizumab (an anti-PD-1 monoclonal antibody), in patients with KRAS-G12C/D/R/V-mutated advanced pancreatic cancer and other refractory solid tumors. Secondary objectives include exploring the correlation between treatment-induced immune responses and clinical outcomes, as well as characterizing the optimal administration regimen for this combination therapy.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	eDC-KRAS vaccine	intravenous injection
DRUG	Tislelizumab	intravenous injection

Timeline

• Start date: 2026-01-20
• Primary completion: 2026-10-31
• Completion: 2026-12-31
• First posted: 2026-02-09
• Last updated: 2026-02-09