Metastatic Cancer Clinical Trial
Official title:
Imaging of Solid Tumors Using FAP-2286
This is a multi-arm prospective trial that evaluates the ability of a novel imaging radiolabeled agents to detect metastatic cancer in participants with solid tumors using a gallium 68 (68Ga-) or copper 64 (64Cu-) FAP-2286 tracer. FAP-2286 is a peptidomimetic molecule that that binds to Fibroblast Activation Protein (FAP). FAP is a transmembrane protein expressed on cancer-associated fibroblasts, and has been shown to be present on a number of solid tumors.
Initially the investigator(s) will focus on imaging breast, pancreas, sarcoma, prostate cancer, bladder cancer, colon cancer, and head and neck cancer. STUDY AIMS 1. Determine the dosimetry for gallium-68 labelled (68Ga-) and 64Cu- FAP-2286. 2. Evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286. 3. Evaluate the ability of FAP-2286 to detect metastatic disease. PRIMARY OBJECTIVES 1. All cohorts: Safety of 68Ga- and 64Cu-FAP-2286. 2. Cohort 1a: determine the organ dosimetry of 68Ga-FAP-2286. 3. Cohort 1b: determine the organ dosimetry of 64Cu-FAP-2286. 4. Cohort 2: To assess the feasibility of detecting tumor uptake using FAP-2286. 5. Cohort 3: To determine the feasibility of detecting metastatic disease using FAP-2286. EXPLORATORY OBJECTIVES 1. To detect the sensitivity of FAP-2286 PET compared to conventional imaging for the detection of metastatic disease, and when available sensitivity compared to Fluorodeoxyglucose (FDG) PET (FDG-PET). 2. Correlation of FAP-2286 uptake with FAP expression determined by immunohistochemistry. 3. Compare biodistribution of 68Ga-FAP-2286 and 64Cu-FAP-2286 in normal organs and blood pool based on renal function. 4. Determine impact of administered dose of FAP-2286 on image quality. 5. Compare the feasibility of detecting tumor uptake using 68Ga-FAP-2286 and 64Cu-FAP-2286 A repeat radiolabeled FAP-2286 PET may be obtained after initiation of subsequent treatment in order to evaluate changes in PET uptake due to treatment effect. Patients will be followed for up to 3 days after the injection of radiolabeled ligand for evaluation of adverse events. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05094804 -
A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
| Recruiting |
NCT05798611 -
Study of ART0380 in Patients With Biologically Selected Solid Tumors
|
Phase 2 | |
| Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
| Recruiting |
NCT05566574 -
A Study of RP-3500 in Combination With Standard Radiation Therapy in People With Solid Tumor Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05036681 -
A Phase II Study of Futibatinib and Pembrolizumab in Metastatic Microsatellite Stable Endometrial Carcinoma
|
Phase 2 | |
| Withdrawn |
NCT00005030 -
SCH 66336 Before Surgery in Treating Patients With Colorectal Cancer That Has Metastasized to the Liver
|
Phase 1 | |
| Recruiting |
NCT05525858 -
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II
|
||
| Recruiting |
NCT04085029 -
Role of Ablative Radiotherapy in the Management of Metastatic Disease: A Patient Data Registry
|
||
| Recruiting |
NCT06058988 -
Trastuzumab Deruxtecan (T-DXd) for People With Brain Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT05981170 -
Rurality Adapted Physical Activity Sport Health
|
||
| Not yet recruiting |
NCT03058809 -
Evaluation of Viatar™ Oncopheresis System in Removing CTC From Whole Blood
|
Phase 1/Phase 2 | |
| Completed |
NCT02529553 -
A Study of LY3076226 in Participants With Advanced or Metastatic Cancer
|
Phase 1 | |
| Terminated |
NCT01929941 -
An Open-Label Study of a Novel JAK-inhibitor, INCB047986, Given in Patients With Advanced Malignancies
|
Phase 1 | |
| Terminated |
NCT00918645 -
Calcium-41 (41Ca) Chloride Aqueous Solution in Diagnosing Patients With Prostate Cancer and Bone Metastasis
|
N/A | |
| Completed |
NCT01302808 -
Romidepsin and Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
|
Phase 1 | |
| Withdrawn |
NCT00769990 -
Genistein in Treating Patients Undergoing External-Beam Radiation Therapy for Bone Metastases
|
Phase 1/Phase 2 | |
| Completed |
NCT00795678 -
Chemotherapeutic Agents in Brain/Breast
|
N/A | |
| Completed |
NCT00557102 -
Cetuximab and Combination Chemotherapy as First-Line Therapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and/or Lung
|
Phase 2 | |
| Recruiting |
NCT00398437 -
Magnetic Resonance Imaging for the Early Detection of CNS Metastases in Women With Stage IV Breast Cancer
|
N/A |