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

NCT05985278 | Recruiting Early Phase 1

• 1 other identifier: 2021KT90
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Preliminary efficacy of [ Lu-177]-Catalase based on tumor response

  From first dose of study drug through 8 weeks post dose

Other Outcomes (1)

• Adverse events for [ Lu-177]-Catalase

  From first dose of [ Lu-177]-Catalase through 8 weeks post dose.

Study Arms (1)

[ Lu-177]-Catalase

EXPERIMENTAL

Participants received \[ Lu-177\]-Catalase intratumoral injection

Drug: [ Lu-177]-Catalase

Interventions

[ Lu-177]-Catalase DRUG

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

[ Lu-177]-Catalase

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients, aged 18-70 years; ECOG score 0 or 1;
• Patients with advanced malignant tumors, such as liver cancer, ovarian cancer, prostate cancer, and so on, clearly diagnosed by pathology and/or cytology;
• Patients with advanced solid tumors who have failed or cannot tolerate standard treatment;
• Expected survival of more than 3 months;
• 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).
• 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;
• 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;
• Can understand and voluntarily sign informed consent, compliance is good

You may not qualify if:

• Severe abnormal liver and kidney function;
• Pregnant, pregnant and lactating women;
• Can not lie flat for half an hour;
• Refuse to join the clinical investigator;
• Suffering from claustrophobia or other mental illness;
• Other conditions deemed unsuitable for participation in the trial by the investigator

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Zhi Yang

Beijing, Beijing Municipality, 100142, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 14, 2023
• Study Start: July 6, 2023
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: August 14, 2023

Record last verified: 2023-07

Locations

CN (1)