NCT07434180

Phase II Trial of Lu-177 FAP-2286 in Patients With Carcinoma of Unknown Primary

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to test if a new radionuclide therapy, called 177-Lu-FAP-2286, works to treat cancer in patients with Cancer of Unknown Primary (CUP).

Detailed description

The aim of the Lu-FAP-CUP trial is to assess preliminary efficacy signal of 177Lu-FAP-2286 in CUP patients with 68Ga-FAPI-46 positive disease. This is a prospective, open label, single site, phase II clinical trial designed to evaluate the safety and efficacy of 177Lu-FAP-2286 monotherapy in CUP patients. Patients who meet all eligibility criteria will be registered into the trial and receive up to 6 cycles of 177Lu-FAP-2286 monotherapy every 28 days.

Conditions

• Cancer of Unknown Primary

Interventions

Type	Name	Description
DRUG	177Lu-FAP-2286	177Lu-FAP-2286 is a novel radioligand therapy. FAP-2286 is a small molecular ligand that binds to the fibroblast activated protein on cancer associated fibroblasts. Lutetium-177 (177Lu) is a nuclear reactor-produced radiometal with a half-life of 6.7 days. 250 mCi of 177Lu-FAP-2286 will be given once every 28 days for a maximum duration of 6 cycles of treatment.

Timeline

• Start date: 2026-06-01
• Primary completion: 2030-06-01
• Completion: 2030-06-01
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

1 site across 1 country: Australia