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

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100023
    • The First Medical Center, Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 68Ga/64Cu-FAPI-XT117 PET/CT; 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.

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.; Drug: 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.; Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	Evaluation of Adverse Events (AE) Using CTCAE	7 days following injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: Sinotau Pharmaceutical Group
• Investigators: Principal Investigator: Ruimin Wang, The First Medical Center, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): December 18, 2023

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: April 3, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: 68Ga-FAPI 64Cu-FAPI
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: XT-XTR016-1-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No