Clinical trial · Interventional
Imaging of Solid Tumors Using FAP-2286
NCT04621435CI-TRIAL-00113556recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Solid Tumors, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Copper-64 labeled (64Cu-) FAP-2286 | Drug | — | UNRESOLVED |
| Gallium-68 labelled (68Ga-) FAP-2286 | Drug | — | UNRESOLVED |
| Positron Emission Tomography (PET) imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- CLOSED - 68Ga-Dosimetry population (Cohort 1a)
- description
- PET imaging will begin 30 +/-10 minutes, 60 +/-15 minutes and 120 +/-20 minutes after injection of 68Ga-FAP-2286. Contrast may be administered if clinically indicated.
- interventionNames
- Drug: Gallium-68 labelled (68Ga-) FAP-2286
- Procedure: Positron Emission Tomography (PET) imaging
- type
- EXPERIMENTAL
- label
- CLOSED - 64Cu-Dosimetry population (Cohort 1b)
- description
- PET imaging will begin 60±15 minutes, 240±30 minutes after injection, and a second PET imaging will be performed 24±2 hours after initial injection of 64Cu-FAP-2286. Contrast may be administered if clinically indicated.
- interventionNames
- Procedure: Positron Emission Tomography (PET) imaging
- Drug: Copper-64 labeled (64Cu-) FAP-2286
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \>= 18 years. 2. Histopathologically confirmed solid tumors in one of the following cohorts: a. Cohort 1 (n=11): measurable disease is not required for this cohort. i. Agnostic to tumor type. b. Cohort 2 (n=95): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases. Note: Presence of absence of metastatic disease for eligibility determination will be assessed by reviewing medical records. Screening imaging will not be conducted for this study. i. Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, colon cancer, or other cancer type. c. Cohort 3 (n=85): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases. Note: Presence of absence of metastatic disease for eligibility determination will be assessed by reviewing medical records. Screening imaging will not be conducted for this study. i. Participants can be imaged at initial staging with what is judged by the treating physician to be high risk disease and where the presence of metastatic disease would greatly impact treatment planning and prognosis. Participants may also be imaged after therapy (surgery, chemotherapy or radiation therapy) if in the determination of the treating physician or investigator there is a high risk of disease recurrence that would also impact treatment plan and/or prognosis. ii. Pathologically confirmed head and neck cancer, bladder cancer, or other cancer type. 3. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation. 2. Known pregnancy.
References
Publications (1)
- DERIVEDKline B, Yadav S, Seo Y, Ippisch RC, Castillo J, Aggarwal RR, Kelley RK, Behr SC, Flavell RR, Lawhn-Heath C, Melisko M, Rugo HS, Wang V, Yom SS, Ha P, Jiang F, Hope TA. 68Ga-FAP-2286 PET of Solid Tumors: Biodistribution, Dosimetry, and Comparison with 18F-FDG. J Nucl Med. 2024 Jun 3;65(6):938-943. doi: 10.2967/jnumed.123.267281. PMID 38697672