Actively Recruiting
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
Led by Lantheus Medical Imaging · Updated on 2025-08-12
26
Participants Needed
5
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 15 years or older who have provided informed consent; those aged 15 to under 18 years must weigh at least 55 kg
- For Part 1: Patients with suspected FAP-expressing metastatic sarcoma confirmed by histology, pathology, or cytology
- For Part 2: Patients with confirmed sarcoma or gastrointestinal tract cancers (esophageal, gastric, pancreatic, colorectal) with suspected FAP expression and planned surgery within 60 days
- Willingness to provide adequate tumor tissue samples from biopsy (Part 1) or planned surgery (Part 2)
- Adequate kidney function with creatinine clearance of at least 60 mL/min
- Women of childbearing potential must have a negative pregnancy test, not be breastfeeding, and agree to use effective contraception during the study and for 28 days after last dose
- Male participants able to father children must agree to use effective contraception and not donate sperm during the study and for 28 days after last dose
You will not qualify if you...
- Unlikely to comply with study procedures or judged unsuitable by the investigator
- Known pregnancy or breastfeeding
- PET scans done within 10 physical half-lives of the PET agent prior to study intervention
- Participation in another clinical trial at screening
- Systemic anti-cancer therapy within 14 days prior to study drug administration (Part 1) or neoadjuvant anti-cancer therapy within 14 days prior (Part 2)
- PET or SPECT imaging with other FAPi agents within 6 months before or after this trial
- History of QT/QTc interval prolongation or taking medications known to prolong QT/QTc
- Additional risk factors for Torsades de Pointes such as heart failure, low potassium, or family history of long QT syndrome
- Evidence of metastatic or advanced inoperable disease (Part 2)
AI-Screening
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Trial Site Locations
Total: 5 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Actively Recruiting
3
Stanford Hospital & Clinics
Stanford, California, United States, 94305
Actively Recruiting
4
BAMF Health, Inc.
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
5
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229-3039
Actively Recruiting
Research Team
E
Eryn Bagley
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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