RecruitingPhase 1Phase 2NCT06298916

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

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)

Sponsor

Lantheus Medical Imaging

Enrollment

26 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Pancreatic Cancer Gastric Cancer Metastatic Sarcoma

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).

Eligibility

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This study uses a radioactive imaging agent called 64Cu-LNTH-1363S to detect a protein called FAP on cancer cells in patients with advanced sarcoma (a soft tissue or bone cancer) or gastrointestinal cancers. The goal is to see if this scan can help identify tumors that might respond to FAP-targeted treatments. **You may be eligible if...** - You are 15 years of age or older (and at least 55 kg if under 18) - You have been confirmed to have metastatic sarcoma or qualifying gastrointestinal cancer - You have tumor tissue available for testing - Your kidney function is adequate - You are not pregnant or breastfeeding and are willing to use contraception **You may NOT be eligible if...** - Your cancer type is not among the eligible sarcoma or gastrointestinal subtypes - You do not have adequate tissue samples available - You have poor kidney function - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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