RECRUITING

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

Conditions

Metastatic Sarcoma Esophageal Cancer Gastric Cancer Pancreatic Cancer Colorectal Cancer Sarcoma FAPi Imaging 64Cu-LNTH-1363S

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2025-07

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06298916

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \<18 years must weigh at least 55 kg. 2. Patients with suspected FAP-expressing metastatic sarcoma. 3. Patients must have histological, pathological, and/or cytological confirmation of a metastatic sarcoma (e.g., undifferentiated pleomorphic sarcoma, liposarcoma, Leiomyosarcoma, myxofibrosarcoma, solitary fibrous tumor, Ewing's sarcoma, synovial sarcoma, sarcoma not otherwise specified, osteosarcoma). 4. Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample), preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of disease; if archival tissue sample is unavailable, a new biopsy should be performed on the most accessible lesion(s) to obtain the tumor tissue sample. 5. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation). 6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug. 7. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.	1. Unlikely to comply with protocol procedures, restrictions and requirements as judged by the Investigator. 2. Known pregnancy or breastfeeding. 3. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention. 4. Patients participating in another clinical trial at the time of screening for this study. 5. Patients who have had systemic anti-cancer therapy administered in the 14 days prior to IP administration. 6. Has undergone or plans to undergo PET or single-photon emission computerized tomography (SPECT) imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial. 7. History of QT/QTc interval prolongation, a marked baseline QT/QTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \> 450 milliseconds) or taking medication known to cause QT/QTc prolongation. 8. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).

Inclusion Criteria

Exclusion Criteria

1. Patient must be ≥ 15 years of age and must have provided written informed consent and assent, where applicable (by patient or legal guardian). Those aged ≥15 to \<18 years must weigh at least 55 kg.
2. Patients with suspected FAP-expressing metastatic sarcoma.
3. Patients must have histological, pathological, and/or cytological confirmation of a metastatic sarcoma (e.g., undifferentiated pleomorphic sarcoma, liposarcoma, Leiomyosarcoma, myxofibrosarcoma, solitary fibrous tumor, Ewing's sarcoma, synovial sarcoma, sarcoma not otherwise specified, osteosarcoma).
4. Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample), preferably from a biopsy of a tumor lesion obtained either at the time of or after the diagnosis of disease; if archival tissue sample is unavailable, a new biopsy should be performed on the most accessible lesion(s) to obtain the tumor tissue sample.
5. Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation).
6. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP must agree to use a highly effective method of contraception during the study and for 28 days after the last injection of the study drug.
7. Male subjects who are able to father a child must agree to avoid impregnating a partner, to adhere to a highly effective method of contraception and to not donate sperm during the study and for 28 days after the last injection of the study drug.

1. Unlikely to comply with protocol procedures, restrictions and requirements as judged by the Investigator.
2. Known pregnancy or breastfeeding.
3. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.
4. Patients participating in another clinical trial at the time of screening for this study.
5. Patients who have had systemic anti-cancer therapy administered in the 14 days prior to IP administration.
6. Has undergone or plans to undergo PET or single-photon emission computerized tomography (SPECT) imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.
7. History of QT/QTc interval prolongation, a marked baseline QT/QTc interval prolongation (e.g., repeated demonstration of a QTc interval, calculated with Fridericia's correction, \> 450 milliseconds) or taking medication known to cause QT/QTc prolongation.
8. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).

Contacts and Locations

Study Contact

Eryn Bagley

CONTACT

978-671-8886

clinicaltrials@lantheus.com

Study Locations (Sites)

City of Hope

Duarte, California, 91010

United States

UC Irvine Health - Chao Family Comprehensive Cancer Center

Orange, California, 92868

United States

Stanford Hospital & Clinics

Stanford, California, 94305

United States

BAMF Health, Inc.

Grand Rapids, Michigan, 49503

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039

United States

Collaborators and Investigators

Sponsor: Lantheus Medical Imaging

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07

Study Completion Date2026-04

Study Record Updates

Study Start Date2025-07

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

FAPi
Imaging
64Cu-LNTH-1363S

Additional Relevant MeSH Terms

Metastatic Sarcoma
Esophageal Cancer
Gastric Cancer
Pancreatic Cancer
Colorectal Cancer
Sarcoma