NCT05784597

A Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Solid Tumors

A Phase I Study to Evaluate the Safety and Dosimetry of 68Ga-labelled OncoFAP Derivatives in Patients with Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Philogen S.p.A. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this trial are to evaluate the safety and dosimetry of \[68Ga\]Ga-OncoFAP for detection/imaging of solid tumors.

Detailed description

Phase I, multicenter study in patients with a confirmed diagnosis of solid tumor among breast cancer, colorectal cancer, oesophageal cancer and pancreatic adenocarcinoma, requiring clinical staging for nodal staging and/or metastatic disease (based on institutional practice and risk stratification). All patients will receive a single intravenous bolus administration of 250 MBq (225 - 275 MBq). \[68Ga\]Ga-OncoFAP biodistribution, PK, and dosimetry of \[68Ga\]Ga-OncoFAP will be assessed based on a series of PET/CT scans, blood and urine sampling.

Conditions

• Breast Cancer
• Colorectal Cancer
• Oesophageal Cancer
• Pancreas Adenocarcinoma

Interventions

Type	Name	Description
DRUG	[68Ga]Ga-OncoFAP administration	All patients will receive a single intravenous bolus administration of 250 MBq (225 - 275 MBq)

Timeline

• Start date: 2023-04-27
• Primary completion: 2024-10-21
• Completion: 2024-10-21
• First posted: 2023-03-27
• Last updated: 2024-11-15

Locations

5 sites across 1 country: Italy