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

Chinese PLA General Hospital (301 Hospital)

Status and phase: Completed; Phase 1

Conditions: Malignant Solid Tumors

Treatments: Drug: 4-6 mCi 68Ga/64Cu-FAPI-XT117; Drug: 2-4 mCi 68Ga/64Cu-FAPI-XT117; Drug: 6-8 mCi 68Ga/64Cu-FAPI-XT117

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05814835

XT-XTR016-1-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

68Ga/64Cu-FAPI-XT117 PET/CT

Experimental group

Description:

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.

Treatment:

Drug: 6-8 mCi 68Ga/64Cu-FAPI-XT117

Drug: 4-6 mCi 68Ga/64Cu-FAPI-XT117

Drug: 2-4 mCi 68Ga/64Cu-FAPI-XT117