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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Malignant Neoplasm
• Intervention / Treatment: Drug: [ 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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100142
      • Recruiting
      • Zhi Yang
      • Contact: Zhi Yang, PhD; Phone Number: 01088196196; Email: pekyz@163.com
      • Contact: Xiaoyi GUO, PhD; Phone Number: 01088196495; Email: 2216392114@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [ Lu-177]-Catalase; Participants received [ Lu-177]-Catalase intratumoral injection	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2023
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Catalase
• Other Study ID Numbers: 2021KT90

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No