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New treatment option for Metastatic Sarcoma
Official title 64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
ClinicalTrials.gov ID: NCT06298916
What this study is testing
What is 64Cu-LNTH-1363S?
64Cu-LNTH-1363S is an investigational medicine, being studied as a potential treatment for metastatic sarcoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join if
- 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...
- 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...
- Patients must be willing to consent to provide sufficient and adequate archived tumor tissue samples (formalin fixed, paraffin embedded sample)...
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- Male people 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...
- 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...
- Male people 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...
What rules you out
- 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...
- 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...
- A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Orange, California, United States
- Stanford, California, United States
- Grand Rapids, Michigan, United States
- Cincinnati, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Orange, California, United States; Stanford, California, United States; Grand Rapids, Michigan, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.