Back to resultsImaging of Solid Tumors Using FAP-2286
Primary Purpose
Solid Tumors, Adult, Metastatic Cancer
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gallium-68 labelled (68Ga-) FAP-2286
Positron Emission Tomography (PET) imaging
Copper-64 labeled (64Cu-) FAP-2286
Sponsored by
About this trial
This is an interventional diagnostic trial for Solid Tumors, Adult focused on measuring PET, 68Ga-FAP-2286, 64Cu-FAP-2286
Eligibility Criteria
Inclusion Criteria:
- Age >= 18 years
Histopathologically confirmed solid tumors in one of the following cohorts:
a. Cohort 1 (n=16): measurable disease is not required for this cohort. i. Agnostic to tumor type. b. Cohort 2 (n=40): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases.
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=30): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases.
i. Patients 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. Patients 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.
- Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
- Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
- Known pregnancy.
Sites / Locations
- University of California, San FranciscoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
68Ga-Dosimetry population (Cohort 1a)
64Cu-Dosimetry population (Cohort 1b)
Participants with metastatic disease (Cohort 2)
Participants without metastatic disease (Cohort 3)
Arm 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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Count of participants with treatment-emergent adverse events
The frequency and severity of treatment emergent adverse events following FAP-2286 injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Proportion of radiation-absorbed doses of radiolabeled FAP-2286 (Cohorts 1a/1b only)
Volumes of interest of 68Ga- and 64Cu- will be drawn around regions identified on the scans, including the liver, spleen, kidneys, urinary bladder, the central sacrum (for hematopoietic marrow) and whole body. Data will be fitted using the Simulation, Analysis, and Modeling Software II (SAAM II) software. Time integrals of activity will be entered into the Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM) software, using the reference adult model. The results from all patients enrolled will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs
Standardized Uptake Values (SUVs) (Cohort 2 only)
The maximum Standardized Uptake Value (SUVmax) will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity.
Tumor-to-background (TBR) Ratio (Cohort 2 only)
TBR ratios will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity. The median and range of the measured TBRs will be reported across all RECIST measurable lesions as a table broken down by location (organ metastases, nodal metastases and bone metastases).
Proportion of positive lesions on FAP-2286 PET (Cohort 3 only)
Conventional imaging will be reviewed in conjunction with the FAP-2286 PET images. Lesions will be characterized as positive on FAP-2286 PET if uptake is greater than 1.5 times higher than mediastinal blood pool and uptake cannot be attributed to physiologic or inflammatory reasons. Conventional imaging will be interpreted as positive by each lesion if the short axis dimension of lymph nodes is greater than 1 centimeter (cm), and organ metastases measure greater than 1 cm in long axis. The gold standard will be the combination of conventional imaging and FAP-2286 PET in combination with clinical follow-up and histopathology (if available). The number of lesions detected by each modality will be compared and sensitivity will be computed. Since this is a proof-of-concept study, it is not powered for the test of agreement. Nevertheless, the agreement will be tested using McNemar's test.
Secondary Outcome Measures
Full Information
NCT ID
NCT04621435
First Posted
November 3, 2020
Last Updated
September 12, 2023
Sponsor
Thomas Hope
Collaborators
Clovis Oncology, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04621435
Brief Title
Imaging of Solid Tumors Using FAP-2286
Official Title
Imaging of Solid Tumors Using FAP-2286
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Hope
Collaborators
Clovis Oncology, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Initially the investigator(s) will focus on imaging breast, pancreas, sarcoma, prostate cancer, bladder cancer, colon cancer, and head and neck cancer.
STUDY AIMS
Determine the dosimetry for gallium-68 labelled (68Ga-) and 64Cu- FAP-2286.
Evaluate the uptake and retention of radiotracer in a variety of solid tumors with FAP-2286.
Evaluate the ability of FAP-2286 to detect metastatic disease.
PRIMARY OBJECTIVES
All cohorts: Safety of 68Ga- and 64Cu-FAP-2286.
Cohort 1a: determine the organ dosimetry of 68Ga-FAP-2286.
Cohort 1b: determine the organ dosimetry of 64Cu-FAP-2286.
Cohort 2: To assess the feasibility of detecting tumor uptake using FAP-2286.
Cohort 3: To determine the feasibility of detecting metastatic disease using FAP-2286.
EXPLORATORY OBJECTIVES
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).
Correlation of FAP-2286 uptake with FAP expression determined by immunohistochemistry.
Compare biodistribution of 68Ga-FAP-2286 and 64Cu-FAP-2286 in normal organs and blood pool based on renal function.
Determine impact of administered dose of FAP-2286 on image quality.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solid Tumors, Adult, Metastatic Cancer
Keywords
PET, 68Ga-FAP-2286, 64Cu-FAP-2286
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
116 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-Dosimetry population (Cohort 1a)
Arm Type
Experimental
Arm 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.
Arm Title
64Cu-Dosimetry population (Cohort 1b)
Arm Type
Experimental
Arm Description
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.
Arm Title
Participants with metastatic disease (Cohort 2)
Arm Type
Experimental
Arm Description
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.
Arm Title
Participants without metastatic disease (Cohort 3)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Gallium-68 labelled (68Ga-) FAP-2286
Other Intervention Name(s)
68Ga-FAP-2286
Intervention Description
The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Intervention Type
Procedure
Intervention Name(s)
Positron Emission Tomography (PET) imaging
Other Intervention Name(s)
PET
Intervention Description
Participants will be scanned for approximately 30 to 45 minutes
Intervention Type
Drug
Intervention Name(s)
Copper-64 labeled (64Cu-) FAP-2286
Other Intervention Name(s)
64Cu-FAP-2286
Intervention Description
The dose will be 3.5 to 5.5 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
Primary Outcome Measure Information:
Title
Count of participants with treatment-emergent adverse events
Description
The frequency and severity of treatment emergent adverse events following FAP-2286 injection will be descriptively reported as classified and graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Time Frame
Up to 3 days
Title
Proportion of radiation-absorbed doses of radiolabeled FAP-2286 (Cohorts 1a/1b only)
Description
Volumes of interest of 68Ga- and 64Cu- will be drawn around regions identified on the scans, including the liver, spleen, kidneys, urinary bladder, the central sacrum (for hematopoietic marrow) and whole body. Data will be fitted using the Simulation, Analysis, and Modeling Software II (SAAM II) software. Time integrals of activity will be entered into the Organ Level INternal Dose Assessment/EXponential Modeling (OLINDA/EXM) software, using the reference adult model. The results from all patients enrolled will be combined to allow the calculation of mean, standard deviation (SD), and range of radiation-absorbed doses to individual organs
Time Frame
Up to 3 days
Title
Standardized Uptake Values (SUVs) (Cohort 2 only)
Description
The maximum Standardized Uptake Value (SUVmax) will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity.
Time Frame
Up to 3 days
Title
Tumor-to-background (TBR) Ratio (Cohort 2 only)
Description
TBR ratios will be calculated for up to five lesions in each patient, with mediastinal blood pool being used as background activity. The median and range of the measured TBRs will be reported across all RECIST measurable lesions as a table broken down by location (organ metastases, nodal metastases and bone metastases).
Time Frame
Up to 3 days
Title
Proportion of positive lesions on FAP-2286 PET (Cohort 3 only)
Description
Conventional imaging will be reviewed in conjunction with the FAP-2286 PET images. Lesions will be characterized as positive on FAP-2286 PET if uptake is greater than 1.5 times higher than mediastinal blood pool and uptake cannot be attributed to physiologic or inflammatory reasons. Conventional imaging will be interpreted as positive by each lesion if the short axis dimension of lymph nodes is greater than 1 centimeter (cm), and organ metastases measure greater than 1 cm in long axis. The gold standard will be the combination of conventional imaging and FAP-2286 PET in combination with clinical follow-up and histopathology (if available). The number of lesions detected by each modality will be compared and sensitivity will be computed. Since this is a proof-of-concept study, it is not powered for the test of agreement. Nevertheless, the agreement will be tested using McNemar's test.
Time Frame
Up to 3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >= 18 years
Histopathologically confirmed solid tumors in one of the following cohorts:
a. Cohort 1 (n=16): measurable disease is not required for this cohort. i. Agnostic to tumor type. b. Cohort 2 (n=40): Metastatic disease present on conventional imaging defined as having RECIST 1.1 measurable disease or multiple bone metastases.
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=30): No evidence of metastatic disease as defined as the absence of RECIST 1.1 measurable disease or bone metastases.
i. Patients 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. Patients 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.
Ability to understand a written informed consent document, and the willingness to sign it.
Exclusion Criteria:
Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation.
Known pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya Aslam
Phone
877-827-3222
Email
Maya.Aslam@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Hope, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maya Aslam
Phone
877-827-3222
Email
Maya.Aslam@ucsf.edu
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Thomas Hope, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Imaging of Solid Tumors Using FAP-2286
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