Clinical trial NCT05985278: Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy
Official title: Clinical Application of Lutetium [177Lu]-Catalase in Tumor Radionuclide Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Advanced Malignant Neoplasm
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: The absorbed radiation dose of tumor and normal organs
timeFrame: From first dose of study drug through 8 weeks post dose
Secondary outcomes:
measure: Preliminary efficacy of [ Lu-177]-Catalase based on tumor response
timeFrame: From first dose of study drug through 8 weeks post dose
Other outcomes:
measure: Adverse events for [ Lu-177]-Catalase
timeFrame: From first dose of [ Lu-177]-Catalase through 8 weeks post dose.
Locations:
city: Beijing
country: China
facility: Zhi Yang
state: Beijing
Study officials:
References: