Clinical Trial · NCT06298916

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)

Overview

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 (64Cu Radiolabeled FAPi PET/CT Imaging Agent) and to compare its imaging biodistribution with FAP expression by immunohistochemistry (IHC) in patients with sarcomas or GIT cancers.

Sponsor

Lantheus Medical Imaging

Phase

Phase 1/2

ClinicalTrials.gov

NCT06298916

Study contact

Eryn Bagley Clinical Trial Lead

eryn.bagley@lantheus.com

Drug / Compound

64Cu-LNTH-1363S

Isotope(s):

Target(s):

Eligibility

Inclusion

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.
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.
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.
Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation).
Patients must be willing to consent to provide sufficient and adequate tumor tissue samples (formalin fixed, paraffin embedded sample), from their planned surgery after participating in study imaging.
Part 1 Patients are eligible to be included in the study only if all of the following criteria apply:
Patients must have histological, pathological, and/or cytological confirmation of a sarcoma or GIT cancers e.g., esophageal, gastric, pancreatic, colorectal cancer.
Patients must have suspected FAP expressing sarcoma or GIT cancers and planned for surgery within 60 days (from study imaging).
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).
Patients with suspected FAP-expressing metastatic sarcoma.
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. Inclusion Criteria: Part 2
Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation).
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.

Exclusion

A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome). Exclusion Criteria: Part 2
Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation.
Evidence of metastatic or advanced, inoperable disease.
Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.
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 drugs known to cause QT/QTc prolongation.
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.
Patients participating in another clinical trial at the time of screening for this study.
Has undergone or plans to undergo PET or SPECT imaging with any other FAPi imaging agent within 6 months prior to or after participating in this trial.
A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome
Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention.
Patients participating in another clinical trial at the time of screening for this study.
Patients who have had systemic anti-cancer therapy administered in the 14 days prior to IP administration.
Known pregnancy or breastfeeding.
Part 1 Patients are excluded from the study if any of the following criteria apply:
Known pregnancy or breastfeeding.
Patients who have had neoadjuvant anti-cancer therapy administered in the 14 days prior to IP administration.
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.
Unlikely to comply with protocol procedures, restrictions and requirements as judged by the Investigator.

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