Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Metastatic Radioactive Iodine Refractory Thyroi… (NCT05410821) | Clinical Trial Compass
CompletedPhase 1
Evaluation of 177Lu-DOTA-EB-FAPI in Patients With Metastatic Radioactive Iodine Refractory Thyroid Cancer
China12 participantsStarted 2022-06-15
Plain-language summary
Increased fibroblast activation protein expression is positively correlated with the dedifferentiation and aggressiveness of thyroid cancer. Radiolabeled fibroblast activation protein inhibitor therapy, also known as radioligand therapy has become a novel treatment for patients with radioactive iodine refractory thyroid cancer and disease progression after first-line treatment. However, a major problem in the therapeutic use of 177Lu-DOTA-FAPI has been its short half-life and fast rate of clearance. This study was designed to evaluate the safety, tolerability, and maximum tolerated dose of a long-lasting radiolabeled fibroblast activation protein inhibitor 177Lu-DOTA-EB-FAPI in mRAIR-TC patients with PD after TKIs treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Ability to understand and willingness to sign a written informed consent document.
✓. Age 18 and older
✓. Confirmed unresectable or metastatic 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)
✓. Progressive disease after TKIs treatment
✓. Eastern Cooperative Oncology Group Performance Status ≤ 3
✓. 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 below Grade 2 or baseline. Completion of entry into 68Ga-FAPI-46 study and completion of scan
✓. Hematologic parameters defined as:
Exclusion criteria
✕. Participant on any chemical anticoagulant including antiplatelet agents (excluding ASA)
What they're measuring
1
Incidence of treatment-related adverse events (safety and tolerability)
Timeframe: From date of involvement until 6 weeks after the second treatment cycles
2
To determine the maximum tolerated dose (MTD)
Timeframe: From date of involvement until 6 weeks after the second treatment cycles
Trial details
NCT IDNCT05410821
SponsorThe First Affiliated Hospital of Xiamen University
. Participants with Class 3 or 4 NYHA Congestive Heart Failure
✕. Clinically significant bleeding within two weeks prior to trial entry (e.g. gastrointestinal bleeding, intracranial bleeding)
✕. Pregnant or lactating women
✕. 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
✕. Has an additional active malignancy requiring therapy within the past 2 years