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RECRUITING
NCT06298916
PHASE1/PHASE2

64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer

Sponsor: Lantheus Medical Imaging

View on ClinicalTrials.gov

Summary

This is a multicenter, open-label, prospective Phase 1/2a study to assess safety and tolerability, establish dosimetry and to identify an optimal imaging dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S, and to compare its imaging biodistribution with FAP expression by IHC in patients with sarcomas or GIT cancers. The study will be conducted in 2 parts (Part 1 and Part 2).

Official title: A Phase 1/2a Study Utilizing 64Cu-LNTH-1363S (64Cu Radiolabeled FAPi PET/CT Imaging Agent) in Patients With Sarcoma or Gastrointestinal Tract Cancer (PHANTOM Trial)

Key Details

Gender

All

Age Range

15 Years - Any

Study Type

INTERVENTIONAL

Enrollment

26

Start Date

2025-08

Completion Date

2026-04

Last Updated

2025-08-12

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

64Cu-LNTH-1363S

64Cu-LNTH-1363S, is a highly selective, high affinity FAP inhibitor (FAPi) that is radiolabeled with Copper-64 (64Cu) for PET/CT Imaging,

Locations (5)

City of Hope

Duarte, California, United States

UC Irvine Health - Chao Family Comprehensive Cancer Center

Orange, California, United States

Stanford Hospital & Clinics

Stanford, California, United States

BAMF Health, Inc.

Grand Rapids, Michigan, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States