First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors

Malignant Solid Tumors Clinical Trial

Official title:

First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05814835
• Other study ID #: XT-XTR016-1-01
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2022
• Est. completion date: December 18, 2023

Study information

• Verified date: December 2023
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.

Description:

20 patients with confirmed diagnosis of malignant solid tumor by histopathology or clinical judgment and required routine 18F-FDG PET/CT imaging were recruited. 68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient in any order(the interval was more than one day and less than four weeks). They were assigned to three 68Ga/64Cu-FAPI-XT117 dose groups, including 3±10% mCi、5±10% mCi and 7 ±10% mCi. PET/CT images were acquired 30min, 60min, 120min after injection. The primary end point was safety, secondary endpoints were accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV), and change in management. Exploring end point was image quality, including qualitative and quantitative evaluation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 18, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. signed the informed consent

• 2. =18 years old

• 3. confirmed as malignant solid tumor by histopathology or clinical judgment

• 4. Patients will undergo 18F-FDG PET/CT examination

Exclusion Criteria:

• 1. Known allergy to components of the investigational drug or its analogues

• 2. suspected to have a certain disease or condition that is not suitable for the study drug

• 3. Known pregnant or lactating women

Related Conditions & MeSH terms

• Malignant Solid Tumors
• Neoplasms

Intervention

Drug:
• 2-4 mCi 68Ga/64Cu-FAPI-XT117
68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 2-4 mCi 68Ga/64Cu-FAPI-XT117 injection.
• 4-6 mCi 68Ga/64Cu-FAPI-XT117
68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 4-6 mCi 68Ga/64Cu-FAPI-XT117 injection.
• 6-8 mCi 68Ga/64Cu-FAPI-XT117
68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient(the interval was more than one day and less than four weeks). PET/CT images were acquired 30min, 60min, 120min after 6-8 mCi 68Ga/64Cu-FAPI-XT117 injection.

Locations

Country	Name	City	State
China	the First Medical Center, Chinese PLA General Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Sinotau Pharmaceutical Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Evaluation of Adverse Events (AE) Using CTCAE	7 days following injection
Secondary	The diagnostic efficacy of 68Ga/64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor	Accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV)	2 months following injection
Secondary	Change in 'treatment strategy questionnaire'	Referring physicians were asked to complete and return 2 questionnaires. The first assessed the existing treatment plan for the patient without the information from 68Ga/64Cu-FAPI-XT PET. The second inquired about intended management after receipt of the written clinical report and the 68Ga/64Cu-FAPI-XT PET images.	2 months following injection