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

NCT06298916 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2025-08-12

No results posted yet for this study

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).

Conditions

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,

Sponsors & Collaborators

  • Lantheus Medical Imaging

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2025-11-30
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06298916 on ClinicalTrials.gov