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Status unknownNCT04841421Updated Apr 12, 2021

Clinical Study on PET Imaging, Distribution and PK of 89Zr-CD147 in Patients With Solid Tumors

An Early Phase 1 interventional study of 89Zr-CD147 in Solid Tumor, sponsored by Sinotau Pharmaceutical Group. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-04-12.

Sponsored by Sinotau Pharmaceutical Group · Early Phase 1, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The primary objective of this study is to observe the distribution of 89Zr-CD147 and radiation dosimetry characteristics in patients with solid tumors. The secondary objective is to observe the pharmacokinetic characteristics of 89Zr-CD147 in patients with solid tumors. This study is a single-center, open-lable study, including 89Zr-CD147 1mCi±10%,89Zr-CD147 3mCi±10% and 89Zr-CD147 5mCi±10% dose group. The trial is expected to last for 2 years from the first patient signing the consent form to the end of the trial.

Read the detailed description

Antibody based positron emission tomography (immuno-PET) imaging is of increasing importance to visualize and characterize tumor lesions. Additionally, it can be used to identify patients who may benefit from a particular therapy and monitor the therapy outcome.

02

Conditions studied

  • Solid Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Sinotau Pharmaceutical Group is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

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

04

Who can participate

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

Inclusion criteria

  1. Patients must be between 18 and 70 years old (including 18 and 70 years old), male or female;
  2. Patients with advanced solid tumors (stage IV): non-small cell lung cancer (NSCLC); Gastric adenocarcinoma; Colorectal adenocarcinoma, etc ;
  3. Patients must have an ECOG performance status of 0-1;
  4. Patients must have a life expectancy ≥ 12 weeks;
  5. Patients must have adequate organ function:

    White blood cell (WBC) count≥4.0x10\^9/L or absolute neutrophil count (ANC) ≥1.5 x 10\^9/L, Platelets ≥100 x 10\^9/L, Hemoglobin≥ 90g/L ; thrombin time or Activated partial thromboplastin time≤1.5ULN; liver and renal function: Total bilirubin≤1.5ULN (upper limit of normal), Alanine aminotransferase (ALT) or aspartate aminotransferase (AST)≤2.5ULN or ≤5ULN (subjects with liver metastasis), alkaline phosphatase (ALP)≤ 2.5ULN (if there is bone metastasis or liver metastasis ALP≤4.5ULN). Urea (BUN)≤1.5ULN, creatinine≤1.5ULN;

  6. Patients must have ≥1 measurable lesion according to RECIST1.1 criteria;
  7. For patients who have partners of childbearing potential: Partner and/or patient must use a method of birth control with adequate barrier protection, deemed acceptable by the principle investigator during the study and for 6 months after last study drug administration.;
  8. Patients must have the ability to understand and sign an approved ICF.

Exclusion criteria

Exclusion Criteria:

  1. There are any of the following conditions, such as brain metastasis (except for asymptomatic primary or metastatic brain tumors that do not need treatment), carcinomatous meningitis, myocardial infarction (within 6 months before enrollment), unstable angina pectoris, or high risk of uncontrollable arrhythmia, coronary artery bypass grafting, cerebrovascular accident (within 6 months before enrollment), congestive heart failure (cardiac function grade III-IV), pulmonary embolism, deep venous thrombosis, Infections that need to be treated with intravenous antibiotics within 2 weeks, and immunosuppressant therapy after organ transplantation;
  2. Primary central nervous system tumor;
  3. HBV DNA≥1000 copies/ml;
  4. HCV-RNA≥1000 copies/ml;
  5. People with positive antibodies to HIV or syphilis;
  6. Patients with acute or subacute intestinal obstruction, or a history of inflammatory bowel disease;
  7. Women who are pregnant, breastfeeding or planning pregnancy;
  8. People who are known to be allergic to the study preparation or its auxiliary materials;
  9. People with a history of psychotropic substance abuse and inability to get rid of it or mental disorders;
  10. Patients who cannot lie for half an hour;
  11. Patients who are allergic to any component of the imaging agent or antibody;
  12. Patients who cannot accept PET/CT imaging;
  13. Situations that other researchers consider unsuitable to participate in the trial.
05

Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    89Zr-CD147 1mCi±10% 10mg dose group

    The activity administered was 1mCi±10% and the mass of radiolabeled CD147 was 10 mg.

    Drug: 89Zr-CD147

  • Experimental
    89Zr-CD147 3mCi±10% 10mg dose group

    The activity administered was 3mCi±10% and the mass of radiolabeled CD147 was 10 mg.

    Drug: 89Zr-CD147

  • Experimental
    89Zr-CD147 5mCi±10% 10mg dose group

    The activity administered was 5mCi±10% and the mass of radiolabeled CD147 was 10 mg.

    Drug: 89Zr-CD147

Interventions

  • Drug89Zr-CD147

    The 89Zr-CD147 is a promising positron emission tomography probe and it is possible to select suitable tumor patients with CD147 expression to benefit from anti-CD147 treatment.

06

What researchers measure

Primary outcomes

  1. Standardized uptake value (SUV)

    Standardized uptake value of tumor

    Time frame: Day 0-7

  2. standardized uptake value ratio (SUVR)

    The ratio of the standardized uptake value of the tumor or suspected tumor lesion to the standardized uptake value of normal tissue

    Time frame: Day 0-7

  3. Radiation dose

    Radiation dose of whole body and major tissues / organs of subjects after administration

    Time frame: Day 0-7

Secondary outcomes

  1. Terminal Half Time (T1/2)

    Pharmacokinetic parameters

    Time frame: Day 0-7

  2. Clearance (CL)

    Pharmacokinetic parameters

    Time frame: Day 0-7

  3. Peak Plasma Concentration (Cmax)

    Pharmacokinetic parameters

    Time frame: Day 0-7

  4. Area under the plasma concentration versus time curve (AUC)

    Pharmacokinetic parameters

    Time frame: Day 0-7

  5. Distribution (dL)

    Pharmacokinetic parameters

    Time frame: Day 0-7

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04841421
Lead sponsor
Sinotau Pharmaceutical Group
Responsible party
Yue Chen (Director, The Affiliated Hospital Of Southwest Medical University) — Principal investigator
First posted
Apr 12, 2021
Start date
May 1, 2021 (estimated)
Primary completion
Mar 1, 2023 (estimated)
Completion
Mar 1, 2024 (estimated)
Last update
Apr 12, 2021

Study contacts

Yue Chen, PHD
Contact
chenyue5523@126.com
13700989831
Lin Qiu, PHD
Contact
qiulin17111210041@163.com
15984011133

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 Apr 2021. You cannot join it, but the record below documents what was studied.

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