177Lu-DOTA-FAPI Clinical Trial
Official title:
68Ga-DOTA-FAPI and 177Lu-DOTA-FAPI Theranostic Pair in Patients With Various Types of Cancer (Locally Advanced or Metastatic Cancer)
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).
| Status | Recruiting |
| Enrollment | 30 |
| Est. completion date | April 15, 2024 |
| Est. primary completion date | April 15, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 90 Years |
| Eligibility | 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-FAPI therapy Inclusion Criteria: (i) Completion of entry into [68Ga]Ga-DOTA-FAPI PET study and completion of scan; (ii) CThe presence of at least one measurable disease by [68Ga]Ga-DOTA-FAPI PET/CT (SUVmax > 10-fold above normal lung or liver); - Exclusion Criteria: (i) 1.Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA); (ii)Participants with Class 3 or 4 NYHA Congestive Heart Failure (iii) Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding); (iv) Pregnant or lactating women; (v)Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e. larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks; (vi)Has an additional active malignancy requiring therapy within the past 2 years; (vii)Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy; (viii)Psychiatric illness/social situations that would interfere with compliance with study requirements; (ix)Cannot undergo PET/CT scanning because of weight limits (350 lbs); (x)INR>1.2; PTT>5 seconds above UNL |
| Country | Name | City | State |
|---|---|---|---|
| China | First affiliated hospital of xiamen university | XiaMen | Fujian |
| Lead Sponsor | Collaborator |
|---|---|
| The First Affiliated Hospital of Xiamen University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | [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 | |
| Secondary | Assessment of organ dosimetry of 177Lu-DOTA-FAPI | Assessment of organ dosimetry of 177Lu-DOTA-FAPI using SPECT/CT imaging at various timepoints | 1-7 days from time of injection |