Status:
RECRUITING
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
Lead Sponsor:
Lantheus Medical Imaging
Conditions:
Metastatic Sarcoma
Esophageal Cancer
Eligibility:
All Genders
15+ years
Phase:
PHASE1
PHASE2
Brief 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 o...
Detailed Description
Part 1 will determine the biodistribution, dosimetry, optimal dose (radioactivity) and imaging time window of 64Cu-LNTH-1363S in 6 evaluable patients with supposed FAP-expressing solid tumors (metasta...
Eligibility Criteria
Inclusion Criteria: Part 1
Patients are eligible to be included in the study only if all of the following criteria apply:
- 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.
- Patients with suspected FAP-expressing metastatic sarcoma.
- 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 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).
- 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.
- 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
- 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.
- 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 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.
- Adequate renal function as determined by a calculated creatinine clearance ≥ 60 mL/min (Cockcroft Gault equation).
- 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.
- 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 Criteria: Part 1
Patients are excluded from the study if any of the following criteria apply:
- Unlikely to comply with protocol procedures, restrictions and requirements as judged by the Investigator.
- Known pregnancy or breastfeeding.
- 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.
- 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.
- 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.
- 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
- Patients who have had neoadjuvant anti-cancer therapy administered in the 14 days prior to IP administration.
- Evidence of metastatic or advanced, inoperable disease.
- Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation.
- Known pregnancy or breastfeeding.
- 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.
- 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.
- 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.
- A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT06298916
Start Date
August 1 2025
End Date
April 1 2026
Last Update
August 12 2025
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope
Duarte, California, United States, 91010
2
UC Irvine Health - Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
3
Stanford Hospital & Clinics
Stanford, California, United States, 94305
4
BAMF Health, Inc.
Grand Rapids, Michigan, United States, 49503