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

Advanced Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985278
• Other study ID #: 2021KT90
• Status: Recruiting
• Phase: Early Phase 1
• Start date: July 6, 2023
• Est. completion date: June 15, 2026

Study information

• Verified date: July 2023
• Source: Peking University Cancer Hospital & Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 15, 2026
• Est. primary completion date: June 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male or female patients, aged 18-70 years; ECOG score 0 or 1;

2. Patients with advanced malignant tumors, such as liver cancer, ovarian cancer, prostate cancer, and so on, clearly diagnosed by pathology and/or cytology;

3. Patients with advanced solid tumors who have failed or cannot tolerate standard treatment;

4. Expected survival of more than 3 months;

5. According to the solid tumor efficacy evaluation criteria , the patient had at least one measurable or evaluable tumor lesion with the longest diameter =10 mm at baseline (in the case of lymph nodes, the short diameter =15 mm). This lesion is suitable for intratumoral injection (the length of the lesion is at least 1 cm or equal).

6. Blood routine and liver and kidney function meet the following criteria: Blood routine: WBC=4.0×109L or neutrophil =1.5×109L, PLT=100×109/L, Hb=90g/L; PT or APTT=1.5ULN; Liver and kidney function: T-Bil=1.5×ULT(upper limit of normal),ALT/AST=2.5ULN or =5×ULT(subjects with liver metastasis), ALP=2.5ULN(ALP= 4.5ULN if there is bone metastasis or liver metastasis); BUN=1.5×ULT, SCr=1.5×ULT;

7. Women must use effective contraception during the study period and for 6 months after the study (effective contraception means sterilization, intrauterine hormone devices, condoms, contraceptives/pills, abstinence or partner vasectomy, etc.); Men should consent to subjects who must use contraception during the study period and for 6 months after the end of the study period;

8. Can understand and voluntarily sign informed consent, compliance is good

The Exclusion Criteria:

1. Severe abnormal liver and kidney function;

2. Pregnant, pregnant and lactating women;

3. Can not lie flat for half an hour;

4. Refuse to join the clinical investigator;

5. Suffering from claustrophobia or other mental illness;

6. Other conditions deemed unsuitable for participation in the trial by the investigator

Related Conditions & MeSH terms

• Advanced Malignant Neoplasm
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Zhi Yang	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Cancer Hospital & Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events for [ Lu-177]-Catalase	Occurrence of adverse events for [ Lu-177]-Catalase	From first dose of [ Lu-177]-Catalase through 8 weeks post dose.
Primary	The absorbed radiation dose of tumor and normal organs	Calculation of effective absorbed dose of tumor in situ injection	From first dose of study drug through 8 weeks post dose
Secondary	Preliminary efficacy of [ Lu-177]-Catalase based on tumor response	Tumor volume based on RECIST 1.1.	From first dose of study drug through 8 weeks post dose