Treatment Using 177Lu-DOTA-EB-FAPI in Patients With Radioactive Iodine Refractory Thyroid Cancer

• Status: Not yet recruiting
• Trial end date: 2025-06-15
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, non-control, non-randomized study to investigate the long-lasting radiolabeled fibroblast activation protein inhibitor based radioligand therapy and evaluate response to 177Lu-DOTA-EB-FAPI in patients with radioactive iodine refractory thyroid cancer. A maximum of 3 cycles of various doses with 1.11GBq (30 mCi), 2.22GBq (60mCi), and 3.33GBq (90 mCi) of 177Lu-DOTA-EB-FAPI will be injected intravenously separately. All patients will undergo 68Ga-FAPI-46 and 18F-FDG PET/CT scans before and after the treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Xiamen University
• Treatments: 1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Ability to understand and willingness to sign a written informed consent document.

2. Age 18 or more years

3. Confirmed presence of radioactive iodine refractory thyroid 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)

4. Eastern Cooperative Oncology Group Performance Status ≤ 2

5. Participant must have completed prior therapy at least 2 weeks (washout period) prior to 68Ga-FAPI-46 PET/CT scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline. Completion of entry into 68Ga-FAPI-46 study and completion of scan

6. Hematologic parameters defined as:

Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL

Blood chemistry levels defined as:

AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN Anticipated life expectancy ≥ 6 months Able to remain motionless for up to 30-60 minutes per scan

Exclusion Criteria:

1. Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)

2. Participants with Class 3 or 4 NYHA Congestive Heart Failure

3. Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)

4. Pregnant or lactating women

5. 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

6. Has an additional active malignancy requiring therapy within the past 2 years

7. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy

8. Psychiatric illness/social situations that would interfere with compliance with study requirements

9. Cannot undergo PET/CT scanning because of weight limits (350 lbs)

10. INR>1.2; PTT>5 seconds above UNL