68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Loc… (NCT04849247) | Clinical Trial Compass
UnknownPhase 1
68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Locally Advanced or Metastatic Cancer)
China30 participantsStarted 2021-04-13
Plain-language summary
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).
Who can participate
Age range18 Years – 90 Years
SexALL
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Inclusion Criteria:
* \[68Ga\]Ga-DOTA-FAPI PET/CT Inclusion Criteria: (i) adult participants (aged 18 years or order); (ii) Confirmed presence of various types of locally advanced or metastatic cancer with measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion \> 1 cm or lymph node \> 1.5 cm in short axis); (iii) Participant must have documented tumor progression during or following at least one prior systemic regimen as established by CT or MRI scan within 28 days of enrollment; (iv) participants who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee. (v) Eastern Cooperative Oncology Group Performance Status ≤ 2; (vi) Participant must have completed prior therapy at least 1 month (washout period) prior to \[68Ga\]Ga DOTA-FAPI PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline;
* Hematologic parameters defined as:
(i)Absolute neutrophil count (ANC) ≥ 1000 cells/mm3; (ii)Platelet count ≥ 100,000/mm3; (iii)Hemoglobin ≥ 8 g/dL;
* Blood chemistry levels defined as:
(i) AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN); (ii) Total bilirubin ≤ 2 times ULN; (iii) Creatinine ≤ 2 times ULN; (iv) Anticipated life expectancy ≥ 6 months; (v) Able to remain motionless for up to 10-20 minutes per scan;
* \[177Lu\]Lu-DOTA-…
What they're measuring
1
68Ga-DOTA-FAPI PET/CT imaging
Timeframe: 1 hours from time of injection
2
[177Lu]Lu-DOTA-FAPI dose escalation therapy
Timeframe: 60 days from time of injection
Trial details
NCT IDNCT04849247
SponsorThe First Affiliated Hospital of Xiamen University