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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed breast cancer, pancreatic adenocarcinoma, sarcoma, castrate-resistant prostate cancer, bladder cancer, or colon cancer.
Cohort 2 (n=40): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 days
Awards & highlights
Study Summary
This trial will test if a new imaging agent can help find cancer that has spread in people with solid tumors. The agent uses either gallium 68 or copper 64 and binds to a protein found on cancer-associated cells.
Who is the study for?
This trial is for adults with solid tumors, including specific cancers like breast, pancreatic, prostate, bladder, or colon cancer. Participants may be at initial high-risk stages or post-treatment with a risk of recurrence. They must understand and sign consent.Check my eligibility
What is being tested?
The trial tests new imaging agents (68Ga- and 64Cu-FAP-2286) that bind to proteins often found in solid tumors. It aims to see how well these tracers can detect metastatic cancer using PET scans in various patient groups.See study design
What are the potential side effects?
Potential side effects are not detailed but may include reactions related to the injection of radiolabeled agents used for PET imaging such as discomfort at the injection site or allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is one of the following types: breast, pancreatic, sarcoma, prostate (castrate-resistant), bladder, or colon.
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My scans show cancer has spread to other parts or bones.
Select...
My cancer has not spread to other parts of my body or bones.
Select...
My cancer is confirmed by lab tests and is not one of the previously mentioned types.
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I am 18 years old or older.
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My cancer is in the head and neck or bladder, confirmed by a pathology report.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Positron-Emission Tomography
Proportion of radiation-absorbed doses of radiolabeled FAP-2286 (Cohorts 1a/1b only)
+2 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Participants without metastatic disease (Cohort 3)Experimental Treatment3 Interventions
Participants without metastatic disease will have PET imaging 50-100 minutes after injection of 68Ga- or 64Cu- FAP-2286. Contrast may be administered if if clinically indicated.
Group II: Participants with metastatic disease (Cohort 2)Experimental Treatment3 Interventions
Participants with metastatic disease will have PET imaging 50-100 minutes after injection of 68Ga- or 64Cu- FAP-2286. Contrast may be administered if clinically indicated.
Group III: 68Ga-Dosimetry population (Cohort 1a)Experimental Treatment2 Interventions
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.
Group IV: 64Cu-Dosimetry population (Cohort 1b)Experimental Treatment2 Interventions
PET imaging will begin 60±15 minutes, 240±30 minutes after injection,and 24±2 hours after injection of 64Cu-FAP-2286. Contrast may be administered if clinically indicated.
Find a Location
Who is running the clinical trial?
Clovis Oncology, Inc.Industry Sponsor
64 Previous Clinical Trials
11,555 Total Patients Enrolled
Thomas HopeLead Sponsor
9 Previous Clinical Trials
1,492 Total Patients Enrolled
Thomas Hope, MDPrincipal Investigator - University of California, San Francisco
Medical School - Boston University
Georgetown University Hospital, Residency in Anesthesiology
11 Previous Clinical Trials
2,117 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer type does not matter and it doesn't need to be measurable for this study group.My doctor considers my cancer high risk and believes imaging could change my treatment plan.My cancer is a solid tumor confirmed by tissue analysis.My cancer is one of the following types: breast, pancreatic, sarcoma, prostate (castrate-resistant), bladder, or colon.My scans show cancer has spread to other parts or bones.My cancer has not spread to other parts of my body or bones.My cancer is confirmed by lab tests and is not one of the previously mentioned types.I am 18 years old or older.My cancer is in the head and neck or bladder, confirmed by a pathology report.
Research Study Groups:
This trial has the following groups:- Group 1: 68Ga-Dosimetry population (Cohort 1a)
- Group 2: 64Cu-Dosimetry population (Cohort 1b)
- Group 3: Participants with metastatic disease (Cohort 2)
- Group 4: Participants without metastatic disease (Cohort 3)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are contributing to the data from this medical trial?
"Absolutely. Clinicaltrials.gov contains up-to-date information on this clinical trial, which was first initiated in December 2020 and last updated in August of 2022. As of now, 86 people are needed for the study at a single location."
Answered by AI
Is there any risk associated with conducting Positron Emission Tomography (PET) scans?
"Our team's calculations lead to a score of 1 for PET imaging with regards to safety, as this is an experimental Phase 1 trial with limited evidence suggesting efficacy and security."
Answered by AI
Are there any remaining opportunities to join this medical experiment?
"Affirmative. The information on clinicaltrials.gov suggests that this research is currently recruiting patients and has been since 14th December 2020, with the last edit occurring on 1st August 2022. This study requires 86 participants to be registered from one particular medical centre/site."
Answered by AI
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