Study Title

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

Study Details

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.

Sponsor:

Philogen S.p.A.

Contacts:

Jacqueline (Mock)

regulatory@philogen.com

+41 43 544 88 02

Marco (Taras)

regulatory@philogen.com

+39 057717816