Using Lutetium-177-Catalase for treating advanced tumors

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

This study is testing a new treatment called Lutetium-177-Catalase for people with advanced tumors that haven't improved with other therapies to see how well it works and if it's safe.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Peking University Cancer Hospital & Institute (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05985278 on ClinicalTrials.gov

What this trial studies

This study evaluates the retention and distribution of Lutetium-177-Catalase after it is injected directly into tumors. Patients will undergo a screening period to determine eligibility, followed by an intratumoral injection of the treatment. The efficacy and safety of the treatment will be assessed one month after injection to decide if further treatment is warranted. The study focuses on patients with advanced malignant tumors who have not responded to or cannot tolerate standard therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with advanced solid tumors that have failed standard treatments.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignant tumors.

How similar studies have performed: While this approach is novel, similar radionuclide therapies have shown promise in treating various cancers.

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

Where this trial is running

Beijing, Beijing Municipality

• Zhi Yang — Beijing, Beijing Municipality, China (RECRUITING)

Conditions: Advanced Malignant Neoplasm