NCT04849247|UnknownPhase 1
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Sponsor study identifier
interventional
30
1 country
1
Study Start
April 13, 2021
Actual (reported)Primary Completion
April 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This is a Phase I, first-in-human study to evaluate the safety and efficacy of the 68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI theranostic pair in patients with various types of cancer (locally advanced or metastatic cancer).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 13, 2021
Actual (reported)April 15, 2021
Actual (reported)April 19, 2021
Actual (reported)April 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
68Ga-DOTA-FAPI PET/CT imaging
Assessment of 68Ga-DOTA-FAPI PET/CT imaging to detect lesions in patients with various types of cancer (locally advanced or metastatic cancer)
1 hours from time of injection
[177Lu]Lu-DOTA-FAPI dose escalation therapy
Frequency of dose-limiting toxicities (DLT) of 177Lu-DOTA-FAPI at escalating dose levels of 177Lu-DOTA-FAPI
60 days from time of injection
Assessment of organ dosimetry of 177Lu-DOTA-FAPI
1-7 days from time of injection
Patients will be undergo 68Ga-DOTA-FAPI PET/CT scans to confirm eligibility for the 177Lu-DOTA-FAPI therapy. Patients with sufficient lesion uptake of 68Ga DOTA-FAPI PET/CT will be offered therapy. Escalating doses of 30-150 mCi of 177Lu-DOTA-FAPI will be administered in a traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort.
Patients will be undergo 68Ga-DOTA-FAPI PET/CT scans to confirm eligibility for the 177Lu-DOTA-FAPI therapy. 10 patients will be enrolled in the dose expansion cohort and received the highest dose achieved in the 177Lu-DOTA-FAPI dose escalation therapy study
PET imaging using 68Ga-DOTA-FAPI will be used to diagnose patients who are eligible for treatment with the 177Lu-DOTA-FAPI.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
First affiliated hospital of xiamen university
Xiamen, Fujian, 0086-361000, China
Long Sun, PhD
The First Affiliated Hospital of Xiamen University
First Submitted
April 15, 2021
First Posted
April 19, 2021
Study Start
April 13, 2021
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
April 15, 2024
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 15, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 19, 2021
Record last verified: 2021-04
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Source: ClinicalTrials.gov.
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