Solid TumorEarly Phase 1NCT04841421
Clinical Study on PET Imaging, Distribution and PK of 89Zr-CD147 in Patients With Solid Tumors
A Early Phase 1 study testing 89Zr-CD147 in people with Solid Tumor, run by Sinotau Pharmaceutical Group.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- 89Zr-CD147
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Mar 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be between 18 and 70 years old (including 18 and 70 years old), male or female;
- Patients with advanced solid tumors (stage IV): non-small cell lung cancer (NSCLC); Gastric adenocarcinoma; Colorectal adenocarcinoma, etc ;
- Patients must have an ECOG performance status of 0-1;
- Patients must have a life expectancy ≥ 12 weeks;
- 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;
Show all 9Show fewer
- Patients must have ≥1 measurable lesion according to RECIST1.1 criteria;
- 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.;
- Patients must have the ability to understand and sign an approved ICF.
Who cannot join
- 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;
- Primary central nervous system tumor;
- HBV DNA≥1000 copies/ml;
- HCV-RNA≥1000 copies/ml;
- People with positive antibodies to HIV or syphilis;
- Patients with acute or subacute intestinal obstruction, or a history of inflammatory bowel disease;
Show all 13Show fewer
- Women who are pregnant, breastfeeding or planning pregnancy;
- People who are known to be allergic to the study preparation or its auxiliary materials;
- People with a history of psychotropic substance abuse and inability to get rid of it or mental disorders;
- Patients who cannot lie for half an hour;
- Patients who are allergic to any component of the imaging agent or antibody;
- Patients who cannot accept PET/CT imaging;
- Situations that other researchers consider unsuitable to participate in the trial.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Study on Positron Emission Tomography (PET) Imaging, Distribution and Pharmacokinetics of 89 Zirconium (Zr)-CD147 in Patients With Solid Tumors
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.
- Conditions
- Solid Tumor
- Being tested
- 89Zr-CD147
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-CD147Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 89Zr-CD147 1mCi±10% 10mg dose group | Experimental | The activity administered was 1mCi±10% and the mass of radiolabeled CD147 was 10 mg. Receives: Drug: 89Zr-CD147 |
| 89Zr-CD147 3mCi±10% 10mg dose group | Experimental | The activity administered was 3mCi±10% and the mass of radiolabeled CD147 was 10 mg. Receives: Drug: 89Zr-CD147 |
| 89Zr-CD147 5mCi±10% 10mg dose group | Experimental | The activity administered was 5mCi±10% and the mass of radiolabeled CD147 was 10 mg. Receives: Drug: 89Zr-CD147 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized uptake value (SUV)
Standardized uptake value of tumor
Measured: Day 0-7
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
Measured: Day 0-7
Radiation dose
Radiation dose of whole body and major tissues / organs of subjects after administration
Measured: Day 0-7
Secondary outcomes (5)
Terminal Half Time (T1/2)
Pharmacokinetic parameters
Measured: Day 0-7
Clearance (CL)
Pharmacokinetic parameters
Measured: Day 0-7
Peak Plasma Concentration (Cmax)
Pharmacokinetic parameters
Measured: Day 0-7
Area under the plasma concentration versus time curve (AUC)
Pharmacokinetic parameters
Measured: Day 0-7
Distribution (dL)
Pharmacokinetic parameters
Measured: Day 0-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Mar 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sinotau Pharmaceutical Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Yue Chen, The Affiliated Hospital Of Southwest Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841421
- Sponsor's protocol ID
- STB017
- Status last verified
- Apr 2021
- First submitted
- 6 Feb 2021
- Last updated
- 12 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Positron Emission Tomography (PET) Imaging, Distribution and Pharmacokinetics of 89 Zirconium (Zr)-CD147 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT04841421
- Acronym / sponsor ID
- STB017
- Conditions
- Solid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sinotau Pharmaceutical GroupIndustry (pharma, biotech, devices)
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Mar 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 12 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 89Zr-CD147 1mCi±10% 10mg dose group | Experimental | Drug: 89Zr-CD147The activity administered was 1mCi±10% and the mass of radiolabeled CD147 was 10 mg. |
| 89Zr-CD147 3mCi±10% 10mg dose group | Experimental | Drug: 89Zr-CD147The activity administered was 3mCi±10% and the mass of radiolabeled CD147 was 10 mg. |
| 89Zr-CD147 5mCi±10% 10mg dose group | Experimental | Drug: 89Zr-CD147The activity administered was 5mCi±10% and the mass of radiolabeled CD147 was 10 mg. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must be between 18 and 70 years old (including 18 and 70 years old), male or female;
- Patients with advanced solid tumors (stage IV): non-small cell lung cancer (NSCLC); Gastric adenocarcinoma; Colorectal adenocarcinoma, etc ;
- Patients must have an ECOG performance status of 0-1;
- Patients must have a life expectancy ≥ 12 weeks;
- Patients must have adequate organ function:
Key exclusion criteria (13 listed)
- 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;
- Primary central nervous system tumor;
- HBV DNA≥1000 copies/ml;
- HCV-RNA≥1000 copies/ml;
- People with positive antibodies to HIV or syphilis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-CD147The 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. | Drug | 89Zr-CD147 1mCi±10% 10mg dose group, 89Zr-CD147 3mCi±10% 10mg dose group, 89Zr-CD147 5mCi±10% 10mg dose group |
Primary outcome
Standardized uptake value (SUV)
Time frame: Day 0-7
Standardized uptake value of tumor
standardized uptake value ratio (SUVR)
Time frame: Day 0-7
The ratio of the standardized uptake value of the tumor or suspected tumor lesion to the standardized uptake value of normal tissue
Radiation dose
Time frame: Day 0-7
Radiation dose of whole body and major tissues / organs of subjects after administration
5 secondary outcomes
Terminal Half Time (T1/2)
Time frame: Day 0-7
Clearance (CL)
Time frame: Day 0-7
Peak Plasma Concentration (Cmax)
Time frame: Day 0-7
Area under the plasma concentration versus time curve (AUC)
Time frame: Day 0-7
Distribution (dL)
Time frame: Day 0-7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 89Zr-CD147 in people with Solid Tumor, run by Sinotau Pharmaceutical Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue Chen, PHD (13700989831, chenyue5523@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Standardized uptake value (SUV) (time frame: Day 0-7). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.