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

NCT05814835 | Completed Phase 1

• 1 other identifier: XT-XTR016-1-01
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malignant Solid Tumors

Keywords

68Ga-FAPI 64Cu-FAPI

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Evaluation of Adverse Events (AE) Using CTCAE

  7 days following injection

Secondary Outcomes (2)

• The diagnostic efficacy of 68Ga/64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor

  2 months following injection

• Change in 'treatment strategy questionnaire'

  2 months following injection

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

2-4 mCi 68Ga/64Cu-FAPI-XT117 DRUG

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.

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

4-6 mCi 68Ga/64Cu-FAPI-XT117 DRUG

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.

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

6-8 mCi 68Ga/64Cu-FAPI-XT117 DRUG

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. signed the informed consent
• \. ≥18 years old
• \. confirmed as malignant solid tumor by histopathology or clinical judgment
• \. Patients will undergo 18F-FDG PET/CT examination

You may not qualify if:

• \. Known allergy to components of the investigational drug or its analogues
• \. suspected to have a certain disease or condition that is not suitable for the study drug
• \. Known pregnant or lactating women

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Sinotau Pharmaceutical Group: collaborator

Study Sites (1)

the First Medical Center, Chinese PLA General Hospital

Beijing, 100023, China

Location

Study Officials

• Ruimin Wang

  the First Medical Center, Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief of nuclear medicine department

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 18, 2023
• Study Start: December 7, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 18, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-12

Locations

CN (1)