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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05985278
Other study ID # 2021KT90
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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