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

• Sponsor: SmartNuclide Biopharma (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05126927
• Collaborator: The First Affiliated Hospital of Soochow University (Other)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• Anticipated 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: Nov 2, 2021
• Actual Primary Completion Date: Jan 19, 2022
• Anticipated Study Completion Date: Aug 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Safety evaluation indicators [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China

Sponsors and Collaborators

• SmartNuclide Biopharma
• The First Affiliated Hospital of Soochow University

Investigators

• Principal Investigator: Liyan Miao, Ph.D, The First Affiliated Hospital of Soochow University
• Principal Investigator: Songbing Qin, The First Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: SmartNuclide Biopharma
• ClinicalTrials.gov Identifier: NCT05126927
• Other Study ID Numbers: SN-2021-01
• First Posted: Nov 19, 2021
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jul 11, 2022