Pilot Study Evaluating Tumor Microenvironment Interaction in Solid Tumor Patients

NCT06922825 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: VICCHN25009
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to compare PET/CT imaging using 68Ga-FAPI-46 to imaging results from standard MRI or CT with contrast in patients with solid tumors undergoing biologic therapy. A total of 50 participants will receive an intravenous injection of 68Ga-FAPI-46 and undergo a PET/CT scan shortly after received the study drug. Imaging will occur before starting standard antibody-based therapy. Participants will then proceed with their treatment, and the study team will monitor them through chart reviews for up to 36 months to evaluate treatment response and any correlation with tumor uptake observed on PET/CT scans.

Conditions

Solid Tumor Cancer; Solid Tumor Malignancy; Cancer; Malignancy

Keywords

Immunotherapy; anti-body based therapy; abt; antibody based therapy; anti body based therapy; cancer; malignancy; solid tumor

Outcome Measures

Primary Outcomes (1)

• Determine the correlative relationship between 68Ga-FAPI-46 and tumor uptake.

  PET/CT uptake of 68Ga-FAPI-46 will be compared to uptake parameters determined by MRI or CT with contrast.

  Day 1 Scan to Day 15 Scan.

Secondary Outcomes (1)

• Assess the ability of 68Ga-FAPI-46 to predict response to ABT

  Day 1 Scan to Day 30 follow up with physician

Study Arms (1)

68 Ga FAPI-46

EXPERIMENTAL

Each participant who meets criteria will receive one dose of 68 Ga FAPI-46 via IV and then receive a whole body PET/CT Scan the same day of infusion. Participants will be asked to have a CT/MRI with contrast approximately one week after the study drug infusion and scan. Researchers will compare PET/CT images using 68Ga-FAPI-46 to compare uptake determined by MRI or CT with contrast as usual Standard of Care.

Drug: 68Ga-FAPI-46

Interventions

68Ga-FAPI-46 DRUG

Participants will receive an IV injection of 68Ga-FAPI-46. Then, shortly after will undergo a PET/CT imaging using the 68Ga-FAPI-46. Additionally, MRI or contrast CT imaging will be conducted, either on the same day or within 14 days.

68 Ga FAPI-46

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years.
• Biopsy confirmed diagnosis of solid tumor malignancy scheduled to undergo antibody-based therapy
• Subjects diagnosed with any stage of disease who will undergo immunotherapy treatment.
• Have acceptable kidney function and clinical lab values.

You may not qualify if:

• Myocardial infarction (MI); cerebrovascular accident (CVA); uncontrolled congestive heart failure (CHF); significant liver disease; or unstable angina within 6 months prior to enrollment
• Females who are currently pregnant or breastfeeding
• Severe renal disease or anuria
• Inability to lie flat or remain still for the duration of the scan.

Sponsors & Collaborators

• Eben Rosenthal: lead
• Vanderbilt University Medical Center: collaborator
• Vanderbilt-Ingram Cancer Center: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

FAPI-46

Study Officials

• Eben Rosenthal, MD

  Vanderbilt University/Ingram Cancer Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Barry and Amy Baker Professor and Chair

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 11, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: January 21, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)