64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 15 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 14 days
- Procedures mentioned: Heart tracing (ECG)
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Part 1 of the study will last approximately 3 weeks for each patient and includes a Screening Period (up to 14 days), a 1-day Intervention Period and a Safety Follow-up Period (7 days post dose)."
- "Part 2 of the study will last approximately 10 to 11 weeks and includes: a Screening Period (up to 14 days), a 1-day Intervention Period, a 1 day Safety Followup Period (Day 2) and a Scheduled Surgery IHC Sample Collection Period (from Day 2 to Day 60)."
- "Both Part 1 and Part 2 of the study will also monitor cardiac safety by detecting changes in HR, T wave, ST segment and other ECG parameters and characterizing the concentration-response relationship of 64Cu-LNTH-1363S for QT and corrected QT interval (QTc) prolongation."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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).
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: Part 1 Patients are eligible to be included in the study only if all of the following criteria apply: 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. Inclusion Criteria: Part 2 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 must have histological, pathological, and/or cytological confirmation of a sarcoma or GIT cancers e.g., esophageal, gastric, pancreatic, colorectal cancer. 3. Patients must have suspected FAP expressing sarcoma or GIT cancers and planned for surgery within 60 days (from study imaging). 4. 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. 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. Exclusion Criteria: Part 1 Patients are excluded from the study if any of the following criteria apply: 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). Exclusion Criteria: Part 2 1. Patients who have had neoadjuvant anti-cancer therapy administered in the 14 days prior to IP administration. 2. Evidence of metastatic or advanced, inoperable disease. 3. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the investigator to be unsuitable for participation. 4. Known pregnancy or breastfeeding. 5. Any PET scan done within 10 physical half-lives of the PET agent prior to receiving study intervention. 6. Patients participating in another clinical trial at the time of screening for this study. 7. 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. 8. 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. 9. A history of additional risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome
Study sites (5)
CA
- City of Hope · Duarte, CA 91010Jessica Liu, Clinical Research Nurse · Study contact · (626)218-0473 · Jesliu@coh.orgYufei Liu, MD · Principal investigatorMore trials in Duarte
- UC Irvine Health - Chao Family Comprehensive Cancer Center · Orange, CA 92868Shyam Srinivas, MD, PhD · Study contact · 877-827-8839 · ucstudy@uci.eduShyam Srinivas, MD, PhD · Principal investigatorMore trials in Orange
- Stanford Hospital & Clinics · Stanford, CA 94305Mikayla Easterling · Study contact · 650-724-3698 · maeast@stanford.eduFarshad Moradi, MD · Principal investigatorMore trials in Stanford
MI
- BAMF Health, Inc. · Grand Rapids, MI 49503Kevin Quinn · Study contact · 616-330-2735 · researchclinicalteam@bamfhealth.comHarshad Kulkarni, MD · Principal investigatorMore trials in Grand Rapids
OH
- Cincinnati Children's Hospital Medical Center · Cincinnati, OH 45229-3039Brian Turpin, MD · Study contact · 1-513-636-2799 · cancer@cchmc.orgBrian Turpin, MD · Principal investigatorMore trials in Cincinnati