Solid Tumor Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | March 1, 2024 |
Est. primary completion date | March 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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: 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sinotau Pharmaceutical Group |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Standardized uptake value (SUV) | Standardized uptake value of tumor | Day 0-7 | |
Primary | 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 | Day 0-7 | |
Primary | Radiation dose | Radiation dose of whole body and major tissues / organs of subjects after administration | Day 0-7 | |
Secondary | Terminal Half Time (T1/2) | Pharmacokinetic parameters | Day 0-7 | |
Secondary | Clearance (CL) | Pharmacokinetic parameters | Day 0-7 | |
Secondary | Peak Plasma Concentration (Cmax) | Pharmacokinetic parameters | Day 0-7 | |
Secondary | Area under the plasma concentration versus time curve (AUC) | Pharmacokinetic parameters | Day 0-7 | |
Secondary | Distribution (dL) | Pharmacokinetic parameters | Day 0-7 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05691608 -
MoleculAr Profiling for Pediatric and Young Adult Cancer Treatment Stratification 2
|
N/A | |
Recruiting |
NCT05580991 -
Intratumoral CAN1012(Selective TLR7 Agonist) in Subjects With Solid Tumors
|
Phase 1 | |
Active, not recruiting |
NCT02846038 -
Understanding Communication in Healthcare to Achieve Trust (U-CHAT)
|
||
Recruiting |
NCT05159388 -
A Study of PRS-344/S095012 (PD-L1x4-1BB Bispecific Antibody-Anticalin Fusion) in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
Completed |
NCT03181854 -
Randomized Controlled Trial of Integrated Early Palliative Care
|
N/A | |
Recruiting |
NCT05981703 -
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06014502 -
Study to Evaluate IMGS-001 Treatment in Patients With Relapsed or Refractory Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04107311 -
Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
|
||
Active, not recruiting |
NCT04078152 -
Durvalumab Long-Term Safety and Efficacy Study
|
Phase 4 | |
Completed |
NCT02250157 -
A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oratecan in Subjects With Advanced Malignancies
|
Phase 1 | |
Recruiting |
NCT05566574 -
A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT03943004 -
Trial of DFP-14927 in Advanced Solid Tumors
|
Phase 1 | |
Recruiting |
NCT06036836 -
Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)
|
Phase 2 | |
Recruiting |
NCT05525858 -
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
|
||
Recruiting |
NCT05798546 -
Treatment of Advanced Solid Tumors With Neo-T(GI-NeoT-02)
|
Phase 1 | |
Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT00479128 -
Bortezomib With Gemcitabine/Doxorubicin in Patients With Urothelial Cancer and Other Solid Tumors
|
Phase 1 | |
Recruiting |
NCT04143789 -
Evaluation of AP-002 in Patients With Solid Tumors
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT04550663 -
NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors
|
Phase 1 | |
Completed |
NCT03980041 -
Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)
|
Phase 2 |