NCT05985278

Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the retention in tumour and distribution behavior of \[Lu-177\]-Catalase after intratumoral injection,and preliminary evaluation the efficacy and safety of \[Lu-177\]-Catalase.

Detailed description

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 2-week screening period to determine eligibility for study entry. At day1, patients who meet the eligibility requirements will be intratumoral injection the \[Lu-177\]-Catalase.The efficacy evaluation will be conducted at one month p.i., whether to continue intratumoral injection the \[Lu-177\]-Catalase, depending on the patient's efficacy and safety results.

Conditions

• Advanced Malignant Neoplasm

Interventions

Type	Name	Description
DRUG	[ Lu-177]-Catalase	\[ 177Lu\]-Catalase is administered by intratumoral puncture every four weeks, and the specific dose is related to the size of the tumor

Timeline

• Start date: 2023-07-06
• Primary completion: 2026-06-15
• Completion: 2026-06-15
• First posted: 2023-08-14
• Last updated: 2023-08-14

Locations

1 site across 1 country: China