NCT05432193

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)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: POINT Biopharma, a wholly owned subsidiary of Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1 study will evaluate the safety and tolerability of \[Ga-68\]-PNT6555 and \[Lu-177\]-PNT6555 in subjects with select solid tumors that have FAP over-expression, in order to determine a recommended Phase 2 dose.

Conditions

• Pancreatic Ductal Adenocarcinoma
• Colorectal Cancer
• Esophageal Cancer
• Melanoma (Skin)
• Soft Tissue Sarcoma
• Head and Neck Squamous Cell Carcinoma
• Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	[Ga-68]-PNT6555	\[Ga-68\]-PNT6555 IV administered as imaging agent for PET/CT
DRUG	[Lu-177]-PNT6555	Patients with FAP-avid disease as determined by the \[Ga-68\]-PNT6555 screening PET/CT will receive \[Lu-177\]-PNT6555 at a fixed dose level for up to 6 doses at an interval of 6 weeks between each dose.

Timeline

• Start date: 2022-07-13
• Primary completion: 2023-11-10
• Completion: 2024-10-02
• First posted: 2022-06-27
• Last updated: 2025-06-25

Locations

4 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study