drugset
drugset / Trial / NCT04712721

Study of [68Ga]-FF58 in Patients With Selected Solid Tumors Expected to Overexpress αvβ3 and αvβ5 Integrins.

NCT04712721 ↗

Phase 0 Terminated 14 enrolled Novartis Pharmaceuticals
Non-randomizedParallel-groupOpen-labelOther

Summary

This is a First-In-Human (FIH) study of \[68Ga\]-FF58 to characterize the imaging properties, safety, biodistribution and dosimetry properties of \[68Ga\]-FF58 in adults with relapsed or refractory (r/r) glioblastoma multiforme (GBM), breast cancer (BC) that has metastasized to the brain, gastroesophageal adenocarcinoma (GEA) or pancreatic ductal adenocarcinoma (PDAC) expected to overexpress alpha-v beta 3 (αvβ3) and alpha-v beta 5 (αvβ5) integrins.

Timeline

Start
2021-10-14
Primary completion
2024-06-18
Completion
2024-07-01

Outcome

Outcome not reported

Stopped (Business): “Business reasons”

Drugs

EvaluationDrugModalityDoseRoute
Subject 68Ga-FF58 Diagnostic / imaging agent 3 mbq/kg Intravenous

Indications

brain neoplasm gastroesophageal adenocarcinoma glioblastoma pancreatic ductal adenocarcinoma