ClinicalTrials.gg
Status unknownNCT05985278Updated Aug 14, 2023

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

An Early Phase 1 interventional study of [ Lu-177]-Catalase in Advanced Malignant Neoplasm, sponsored by Peking University Cancer Hospital & Institute. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by Peking University Cancer Hospital & Institute · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2023), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Advanced Malignant Neoplasm
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In context

Lead sponsor

Peking University Cancer Hospital & Institute is the lead sponsor of 266 studies on the registry; 128 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    [ Lu-177]-Catalase

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

    Drug: [ Lu-177]-Catalase

Interventions

  • 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

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What researchers measure

Primary outcomes

  1. The absorbed radiation dose of tumor and normal organs

    Calculation of effective absorbed dose of tumor in situ injection

    Time frame: From first dose of study drug through 8 weeks post dose

Secondary outcomes

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

    Tumor volume based on RECIST 1.1.

    Time frame: From first dose of study drug through 8 weeks post dose

Other outcomes

  1. Adverse events for [ Lu-177]-Catalase

    Occurrence of adverse events for \[ Lu-177\]-Catalase

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

07

Study locations

1 of 1 sites recruiting
  • Zhi Yang
    Beijing, Beijing Municipality 100142, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2023 (actual). Primary completion is estimated for Jun 2026, 35 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2023
First posted
Aug 14, 2023
StartActual
Jul 6, 2023
Primary completionEst.
Jun 15, 2026
CompletionEst.
Jun 15, 2026
Last update
Aug 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05985278
Responsible party
Sponsor
First posted
Aug 14, 2023
Start date
Jul 6, 2023
Primary completion
Jun 15, 2026 (estimated)
Completion
Jun 15, 2026 (estimated)
Last update
Aug 14, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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