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

Phase 1

Completed

• Conditions: Malignant Solid Tumors
• Interventions: Drug: 2-4 mCi 68Ga/64Cu-FAPI-XT117; Drug: 4-6 mCi 68Ga/64Cu-FAPI-XT117; Drug: 6-8 mCi 68Ga/64Cu-FAPI-XT117

• Registration Number: NCT05814835
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-12-07
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-04-03
• Study First Posted: 2023-04-18
• Primary Completion: 2023-11-30
• Status Verified: 2023-12
• Study Completion: 2023-12-18
• Last Update Submitted: 2023-12-19
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga/64Cu-FAPI-XT117 PET/CT	2-4 mCi 68Ga/64Cu-FAPI-XT117	Each patient will receive 2-4 mCi, 4-6 mCi or 6-8 mCi 68Ga/64Cu-FAPI-XT117 intravenously (IV), and then PET/CT scanning within the specified time. On another day, patients receive 18F-FDG and then undergo PET/ CT.
68Ga/64Cu-FAPI-XT117 PET/CT	4-6 mCi 68Ga/64Cu-FAPI-XT117	Each patient will receive 2-4 mCi, 4-6 mCi or 6-8 mCi 68Ga/64Cu-FAPI-XT117 intravenously (IV), and then PET/CT scanning within the specified time. On another day, patients receive 18F-FDG and then undergo PET/ CT.
68Ga/64Cu-FAPI-XT117 PET/CT	6-8 mCi 68Ga/64Cu-FAPI-XT117	Each patient will receive 2-4 mCi, 4-6 mCi or 6-8 mCi 68Ga/64Cu-FAPI-XT117 intravenously (IV), and then PET/CT scanning within the specified time. On another day, patients receive 18F-FDG and then undergo PET/ CT.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	7 days following injection	Evaluation of Adverse Events (AE) Using CTCAE

Secondary Outcome Measures

Name	Time	Method
Change in 'treatment strategy questionnaire'	2 months following injection	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.
The diagnostic efficacy of 68Ga/64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor	2 months following injection	Accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV)

Trial Locations

Locations (1)

the First Medical Center, Chinese PLA General Hospital; 🇨🇳 Beijing, China