NCT04621435 Imaging of Solid Tumors Using FAP-2286
| NCT ID | NCT04621435 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Thomas Hope |
| Condition | Solid Tumors, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 191 participants |
| Start Date | 2020-12-14 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 191 participants in total. It began in 2020-12-14 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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, or colon cancer. ii. Pathologically confirmed cancer other than noted above (basket subgroup, n=10). 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 definitive 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 or bladder cancer. 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.
Contact & Investigator
Thomas Hope, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT04621435 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04621435 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04621435 currently recruiting?
Yes, NCT04621435 is actively recruiting participants. Contact the research team at Maya.Aslam@ucsf.edu for enrollment information.
Where is the NCT04621435 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT04621435 clinical trial?
NCT04621435 is sponsored by Thomas Hope. The principal investigator is Thomas Hope, MD at University of California, San Francisco. The trial plans to enroll 191 participants.