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A PET Imaging Agent to Assess the Level of Tumor Tissue-infiltrating CD8 + T Cells in Patients With Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05126927
Recruitment Status : Recruiting
First Posted : November 19, 2021
Last Update Posted : July 11, 2022
Sponsor:
Collaborator:
The First Affiliated Hospital of Soochow University
Information provided by (Responsible Party):
SmartNuclide Biopharma

Brief Summary:
Primary objective To investigate the safety and tolerability profile of 68Ga- NODAGA-SNA006 in patients with solid tumors; To investigate the radiation absorbed dose characteristics of 68Ga-NODAGA-SNA006 in patients with solid tumors; To investigate the distribution profile of 68Ga-NODAGA-SNA006 in patients with solid tumors. Secondary objectives To investigate the optimal administration dose and radiation safety profile of 68Ga-NODAGA-SNA006; To investigate the PET imaging characteristics and high-quality imaging time window of 68Ga-NODAGA-SNA006 in patients with solid tumors; To explore the correlation between PET imaging characteristics of 68Ga-NODAGA-SNA006 binding to CD8 and histological CD8 expression characteristics; To explore peripheral blood T lymphocyte differentiation (CD8, CD4, CD3, etc.) in patients with solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Biological: 68Ga-NODAGA-SNA006 Early Phase 1

Detailed Description:

The study had a dose-escalation, open-label design. Intravenous injection of SNA006 was used to observe its safety tolerance, radiation absorbed dose, distribution, and PET imaging characteristics in patients with solid tumors. The study consists of three phases, namely, a screening period, a trial period, and a safety follow-up period.

  1. Safety evaluation Observe any AE occurred in all subjects during the clinical study, record the clinical features, severity, occurrence time, end time, duration, treatment measures and outcome, and determine the correlation between any AE and the study drug.
  2. efficacy evaluation 2.1. Evaluation of imaging characteristics In this clinical trial, PET imaging characteristics will be evaluated by an independent imaging evaluation committee, and the PET imaging operating procedures and parameters will be detailed in the PET/CT standard operating procedures. 2.2. Evaluation of correlation between imaging expression and immunohistochemistry.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study to Evaluate the Safety Tolerability, Radiation Absorbed Dose,Distribution, PET Imaging and Histological Expression of 68GA-Nodaga-SNA006 in Patients With Solid Tumors.
Actual Study Start Date : November 2, 2021
Actual Primary Completion Date : January 19, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 68Ga-NODAGA-SNA006
A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors
Biological: 68Ga-NODAGA-SNA006
A PET contrast agent to assess the level of tumor tissue-infiltrating CD8 + T cells in patients with solid tumors




Primary Outcome Measures :
  1. Safety evaluation indicators [ Time Frame: 12 months ]
    AE/SAE/SUSAR. To observe AE/SAE/SUSAR of subjects during trial period, until 12 months after trial finished.


Secondary Outcome Measures :
  1. Immunogenicity evaluation [ Time Frame: 1 week ]
    ADA blood samples were collected twice, and tested in an independent third party central laboratory. Then, ADA positive rate were analysied.

  2. Evaluation of imaging characteristics [ Time Frame: 12 months ]
    Target/background ratio in PET imaging of tumor lesions was calculated, compared target lesions with contralateral lesions, liver and muscle.

  3. Evaluation of the correlation between imaging expression and immunohistochemistry [ Time Frame: 12 months ]
    Immunohistochemical analysis (third-party independent central laboratory testing) was performed on the collected tumor tissue samples, and the scoring results were compared with the imaging expression results to calculate the sensitivity, specificity and other results.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-70 years (including boundary values);
  2. Have behavioral ability, and voluntarily participate in this clinical study, and sign the informed consent form (ICF);
  3. Performance status (ECOG) score 0-1 points (see Appendix 1 for details);
  4. Basal heart rate 60-100 beats/min (including boundary values);
  5. Blood pressure measurement < hypertension grade 1 level (including a history of hypertension, systolic blood pressure < 140 and diastolic blood pressure < 90 mmHg by exercise or drug treatment);
  6. Patients with confirmed solid tumors;
  7. Patients who must have at least one image-measurable lesion according to the evaluation criteria for solid tumors (RECISTv1.1);
  8. Imaging results show that at least one tumor lesion can be needle biopsy or surgical treatment to obtain specimens (enhanced CT, enhanced MRI or 18F-FDG PET/CT results are acceptable);
  9. Patients with immunohistochemical CD8 results within the past month;

Exclusion Criteria:

  1. Those who are unable to follow this clinical trial protocol well enough to make visits, or undergo relevant examinations, or treatment.
  2. Those who have extremely poor nutritional status and cannot tolerate the trial
  3. Those with comorbid major diseases or other malignancies (except those that have healed by one year or do not require additional treatment)
  4. Those with known severe allergy to SNA006, similar drugs or excipients. Specialized conditions
  5. Patients who have undergone previous splenectomy or splenic disease such as hypersplenism or splenomegaly
  6. Patients with brain metastases.
  7. Serum virology tests: positive results for any of hepatitis B virus surface antigen, hepatitis C virus antibodies, syphilis-specific antibodies or those who cannot be determined to be negative for human immunodeficiency virus antibodies
  8. Patients who have not recovered from a serious infection
  9. Patients with drug/alcohol abuse, severe mental disorders
  10. Those with claustrophobia, emotional instability, acute persistent spasticity or inability to keep both arms up and lying flat for 15-30 minutes
  11. Those who have participated in any other clinical trial within 3 months prior to screening
  12. Women who are pregnant or breastfeeding.
  13. Those who, in the opinion of the investigator, are not suitable to participate in this clinical study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05126927


Contacts
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Contact: Hua Zhang (86) 512 67972858 sdfyy8040@126.com
Contact: Yan Wang, Ph.D (86) 512 67972858 0814wangyan@163.com

Locations
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China, Jiangsu
The First Affiliated Hospital of Soochow University Recruiting
Suzhou, Jiangsu, China
Contact: Yan Wang, Ph.D    (86) 512 67972858    0814wangyan@163.com   
Sponsors and Collaborators
SmartNuclide Biopharma
The First Affiliated Hospital of Soochow University
Investigators
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Principal Investigator: Liyan Miao, Ph.D The First Affiliated Hospital of Soochow University
Principal Investigator: Songbing Qin The First Affiliated Hospital of Soochow University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SmartNuclide Biopharma
ClinicalTrials.gov Identifier: NCT05126927    
Other Study ID Numbers: SN-2021-01
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms