NCT05981235

Phase 1 Trial of AZD6422 in CLDN18.2+ GI Tumors

FTiH, Phase 1 Investigator-Initiated Trial (IIT) to Evaluate the Safety, Feasibility, Cellular Kinetics, and Preliminary Antitumor Activity of AZD6422 in Adult Participants With Advanced or Metastatic CLDN18.2+ GI Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a FTiH, Phase 1 IIT to evaluate the safety, feasibility, cellular kinetics (CK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of AZD6422 in adult participants with advanced or metastatic CLDN18.2+ GI tumors.

Detailed description

Qualified researchers can request access to anonymized individual patient-level data from sponsor or the collaborator group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the sponsor disclosure commitment. Yes, indicates that sponsors are accepting requests for IPD, but this does not mean all requests will be shared.

Conditions

• Gastrointestinal Tumors

Interventions

Type	Name	Description
BIOLOGICAL	AZD6422 CLDN18.2 CAR-T product	AZD6422 CAR-T product infusion after pre-conditioning

Timeline

• Start date: 2023-12-14
• Primary completion: 2025-06-25
• Completion: 2025-06-25
• First posted: 2023-08-08
• Last updated: 2025-07-31

Locations

1 site across 1 country: China