177Lu-DOTA-EB-TATE for Metastatic Oncocytic Thyroid Cancer
This study is testing a new radioactive drug, 177Lu-DOTA-EB-TATE, for adults with metastatic oncocytic (Hurthle-cell) thyroid cancer that has not responded to radioactive iodine treatment. This drug is designed to target a specific protein found on these cancer cells. You may be able to join if you are 18 or older, have this type of thyroid cancer that has spread, and your cancer has progressed recently. The main goals are to find the safest and most effective dose of 177Lu-DOTA-EB-TATE and to see if it can improve how long people live without their cancer getting worse (progression-free survival). The study is currently recruiting 18 participants.
- Study design
- This is an interventional study with a planned enrollment of 18 participants. The phase is not specified, but it aims to determine optimal dosing and efficacy.
- What's involved
- You will undergo screening, including a physical exam, blood tests, imaging scans, and a heart function test. You will receive 4 infusions of 177Lu-DOTA-EB-TATE, spaced 8 to 12 weeks apart, along with amino acid infusions for kidney protection.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess progression-free survival at 6 months after the last cycle of 177Lu-DOTA-EB-TATE.
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NCT06991738
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Not Yet Recruiting
PHASE1Ages 18+InterventionalTreatmentNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government-funded
~18 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:68Ga-DOTA-TATE PET ScanAmino acid infusions177Lu-DOTA-EB-TATE
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine the optimal dose of 177Lu-DOTA-EB-TATE that is both safe and shows sufficient efficacy for treatment of metastatic HTC based on TITE-BOIN12 design of phase 1/2 clinical trial [1, 2].
Measured over 8-12 weeks
+2 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Joanna Klubo-Gwiezdzinska, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Aged 18 years or older.
Metastatic RAI-non-responsive and/or RAI-non-avid oncocytic (Hurthle cell) thyroid cancer.
Progressive disease by RECIST 1.1 criteria, with or without symptoms within the last 12 months. This applies to patients with non-measurable disease by RECIST 1.1 criteria, who will be eligible if they have evidence of progression as defined by the development of new lesions within the last 12 months.
High expression of SSTR2 in at least one metastatic lesion as documented by 68Ga-DOTATATE PET/CT with SUVmax \> SUVmax of the liver consistent with Krenning score of \>2 or SUVmax \>= 13 based on scan performed within 12 weeks of anticipated enrollment.
Exclusion
Pregnant or breastfeeding.
NET/PET score of 5 by imaging with 68Ga-DOTATATE PET/CT and 18FDG-PET/CT and defined more than 2 lesions that are SSTR2 negative but 18FDG positive and/or more than 2 lesions that have significantly higher uptake of 18FDG than 68Ga-DOTATATE
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 177Lu-DOTA-EB-TATE as assessed from medical record.
Patient weight \> 500 lbs. (due to the PET scanner table limit).
Inability to tolerate at least one modality of diagnostic anatomic imaging, such as CT or MRI.
Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 4 weeks or 4 half-lives (whichever is longer), before the first administration of study drug.
Previous surgery \< 6 weeks prior to the start of participation in this study, or participant has not fully recovered from major surgery, or has suffered significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 3 months after the last dose of study drug.
Life expectancy \< 6 months as assessed by the treating physician.
Karnofsky performance status scale \< 70%.
Inability or unwillingness to use adequate contraception prior to study entry and for the duration of study participation, including follow-up (7 months after the last dose of study drug for women and 4 months for men). The adequate contraception consists of intrauterine device, contraceptive implant, hormonal contraception or a double-barrier method. If the patient is status post tubal ligation, status post hysterectomy and/or oophorectomy, or their male partners are status post vasectomy, no additional method of contraception is required.
Deteriorated renal function, as indicated by a creatinine clearance \<60 mL/min calculated by the Cockcroft-Gault Equation. The calculated creatinine clearance can be confirmed by measured creatinine clearance.
Having only one functional kidney, due to potential nephrotoxicity.
Patients who have had any prior EBRT dose to either kidney.
Deteriorated bone marrow function, as indicated by:
Hemoglobin (Hb) \< 8.0 g/dL
White blood cell (WBC) \< 2 x10\^3/uL
Absolute neutrophil count (ANC) \< 1.0 x 10\^3/L
Platelets \<100 x 10\^3/microL
Deteriorated liver function, as indicated by one or more of the following:
International normalized ratio (INR) \> 2.0 for patients that are not on Coumadin
Prothrombin time (PTT) \> 2 x ULN
Total bilirubin \> 3 mg/dL
Serum albumin \< 3.0 g/dL unless prothrombin time is within the normal range
Alanine aminotransferase (ALT) \> 3 x ULN
Aspartate aminotransferase (AST) \> 3 x ULN.
Previous local therapy \<4 weeks prior to study entry.
Extended QTc interval above 480 ms confirmed by 2 ECGs. If the first ECG conducted at the screening visit shows extended QTc interval, potential participants will be asked to repeat an ECG within 30 days to confirm. The second ECG can be conducted at NIH CC or at their outside provider, at their potential expense.
Toxicities from prior therapies that have not resolved to grade 1 or grade 0 excluding dry mouth syndrome from previous RAI and grade 2 anemia/leukopenia as Hgb\>=8 g/dl, WBC \>=2 x10\^3/uL and ANC \>= 1.0 x 10\^3 are acceptable for enrollment.
Active and clinically significant bacterial, fungal, or viral infection, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness. Radiolabeled ligands may affect the immune response, so people with active and clinically significant infections may become too immunocompromised through participation in this study.
Known brain metastases and/or carcinomatous meningitis unless these metastases have been treated and stabilized.
Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Prior external beam radiation therapy involving \>25% of the bone marrow.
Unmanageable urinary incontinence rendering the administration of 177Lu-DOTA-EB-TATE unsafe.
Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.
Is unwilling or unable to establish care with a local provider outside of NIH CC
Inability to understand or unwilling to sign a written informed consent document.
What this trial measures
- To determine the optimal dose of 177Lu-DOTA-EB-TATE that is both safe and shows sufficient efficacy for treatment of metastatic HTC based on TITE-BOIN12 design of phase 1/2 clinical trial [1, 2].8-12 weeks
- To identify the dose-limiting toxicities (DLTs) of escalating doses of 177Lu DOTA EB TATE based on individualized dosimetry.8-12 weeks
- To assess the efficacy of 177Lu DOTA EB TATE to improve upon progression-free survival (PFS) at 6 months after the last cycle of the study drug in participants with metastatic RAI-non-responsive HTC.8-12 weeks