Clinical Trials

Overview

Clinical trials are research studies used to find out whether new treatments are safe and effective, and work better than current treatments. Clinical trials are strictly monitored and carefully evaluated.

Trial

Indication

Medicine

TYPE

Description

A multi-center Phase 3 open-label, randomized study.
A man with his arms crossed, smiling

The SPLASH Study is for men with prostate cancer that has spread beyond the prostate and progressed after hormone therapy. Your doctor will determine whether the SPLASH study may be right for you.

Learn More at the official trial website or NCT04647526 at ClinicalTrials.gov

Phase 1

FAPi Radioligand OpeN-Label, Phase 1 Study to Evaluate Safety, Tolerability and DosImetry of [Lu-177]-PNT6555; A Dose Escalation Study for TReatment of Patients With Select Solid Tumors (FRONTIER).

Learn more about NCT05432193 at ClinicalTrials.gov

Prospective single arm, multicenter study

Sponsored by the University Health Network (Toronto, Ontario, Canada), a prospective single arm, multicenter study to evaluate the efficacy and safety of Lutetium-177 Octreotate in patients with neuroendocrine tumors who has positive Somatostatin receptor identified by 68Ga-DOTATATE

Learn more about NCT027437411 at ClinicalTrials.gov

POINT is committed to accelerating the discovery, development, and global access to life-changing radioligand therapies.  We are focused on conducting clinical studies required by regulatory authorities to fully answer important scientific questions about the potential risks and benefits of our investigational products and to obtain regulatory approval, thereby making our medicines available to patients who are most likely to benefit from this therapy, as quickly as possible.

At the same time, we understand that there are individuals who may have exhausted all available treatment options and may not be eligible for available clinical trials.  For this reason, although expanded access is not yet an option for any of POINT’s investigational radioligands, we are working diligently with our partner LANTHEUS to establish a 177Lu-PNT2002 Expanded Access Program in the United States.  More information will be available once agreement on the protocol has been reached with FDA.