NCT05549804

A Study of Intratumoral KL340399 in Patients With Advanced Solid Tumors

A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of KL340399 Intratumoral in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 intratumoral in patients with advanced solid tumors.

Detailed description

This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 intratumoral in patients with advanced solid tumors.The dose increasing method of "BLRM" is used to explore the safety, tolerance and determine the maximum tolerated dose(MTD).

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	KL340399 Intratumoral	KL340399 is a STING-activating. The strength of KL340399 is 0.2 mg/vial or 0.2 mg/vial.

Timeline

• Start date: 2022-08-30
• Primary completion: 2025-04-21
• Completion: 2025-04-21
• First posted: 2022-09-22
• Last updated: 2025-12-05

Locations

1 site across 1 country: China