Differentiated Thyroid CancerPhase 2SETHYNCT06235216
Sacituzumab govitEcan in THYroid Cancers
A Phase 2 study testing Sacituzumab govitecan in people with Differentiated Thyroid Cancer and Anaplastic Thyroid Cancer, run by Grupo Espanol de Tumores Neuroendocrinos at 11 sites in Spain.
Trial summary
SETHY is a prospective, multicohort, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study of sacituzumab govitecan in patients with advanced or metastatic radioactive-iodine refractory differentiated thyroid carcinoma (DTC) or anaplastic thyroid carcinoma (ATC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Differentiated Thyroid Cancer, Anaplastic Thyroid Cancer
- What is being tested?
- Sacituzumab govitecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 11 sitesSpain
- Study dates
- 13 Sep 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.
- Patient is ≥ 18 years of age.
- Patient has histologically confirmed metastatic or locally advanced unresectable radioactive-iodine refractory differentiated thyroid cancer (cohort A) or anaplastic thyroid carcinoma (cohort B).
- Prior therapy in each cohort:
- Cohort A: Patients must have experienced progression on at least one previous treatment line with approved systemic therapies (Sorafenib, Lenvatinib or Cabozantinib) and a maximum of 3 prior systemic therapies.
- Cohort B: Patients should be included in first-line setting or after failure of any systemic therapy (up to 1 prior treatment lines).
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- Patient has radiographically documented and measurable metastatic or locally advanced disease at baseline.
- An archival tumor tissue sample should be available for submission to the central laboratory for translational studies. If an archival tumor tissue sample is not available, a new biopsy tissue sample should be provided. No central pathological review will be needed to include the patient in the trial.
- Patient has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- The following baseline laboratory data without transfusional support:
- Neutrophil count (ANC) ≥ 1,500/mm3.
- Platelet count ≥ 100 × 109/L.
- Hemoglobin ≥ 9 g/dL.
- Serum bilirubin ≤ 1.5 × upper limit of normal (ULN). Note: patients with Gilbert's disease are excluded.
- Serum albumin > 3 g/dL.
- Creatinine clearance (CrCl) ≥ 60 mL/min as estimated by the Cockroft-Gault formula or as measured by 24 hour urine collection (GFR can also be used instead of CrCl).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN or ≤ 5 xULN for patients with liver metastases.
- Female patients must either:
- Be of nonchildbearing potential:
- I)Postmenopausal (defined as at least 1 year without any menses) prior to screening , or II) Documented surgically sterile (e.g.hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or bilateral tubal occlusion).
- Those who are amenorrheic due to an alternative medical cause are not considered postmenopausal and must follow the criteria for childbearing potential subjects.
- OR
- If of childbearing potential:
- Agree not to try to become pregnant during the study and for at least 6 months after the final study drug administration, II) And have a negative urine or serum pregnancy test within 7 days prior to Day 1 (females with false positive results and documented verification of negative pregnancy status are eligible for participation), III) And if heterosexually active, agree to abstinence (if in line with the usual preferred lifestyle of the patient) or consistently use a condom plus 1 form of highly effective birth control per locally accepted standards starting at screening and throughout the study period and for at least 6 months after the final study drug administration.
- Female patients must agree not to breastfeed or donate ovules starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.
- Male patients must not donate sperm starting at screening and throughout the study period, and for at least 6 months after the final study drug administration.
- Male patients with a partner with childbearing potential, or who is pregnant or breastfeeding must agree to abstinence or use a condom plus 1 form of highly effective birth control throughout the study period and for at least 6 months after the final study drug administration.
- Patient agrees not to participate in another interventional study while on treatment in the present study.
Who cannot join
- Patient has central nervous system (CNS) metastases.
- Patient has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
- Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Patient has a history of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
- Note: Patients with non melanoma skin cancer, curatively treated localized prostate cancer, or carcinoma in situ of any type (if complete resection was performed) are allowed.
- Patient has known active Hepatitis B or active hepatitis C:
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- Patients who test positive for hepatitis B surface antigen (HBsAg). Patients who test positive for hepatitis B core antibody (anti-HBc) will require HBV DNA by quantitative polymerase chain reaction (PCR) for confirmation of active disease.
- Patients who test positive for HCV antibody. Patients who test positive for HCV antibody will require HCV RNA by quantitative PCR for confirmation of active disease. Patients with a known history of HCV or a positive HCV antibody test will not require a HCV antibody at screening and will only require HCV RNA by quantitative PCR for confirmation of active disease.
- Patients who test positive for HIV antibody.
- Patient has a known history of human immunodeficiency virus (HIV) infection (HIV 1 or 2) with detectable viral load OR taking medications that may interfere with SN-38 metabolism.
- Patient has documented history of a cerebral vascular event (stroke or transient ischemic attack), or the following criteria for cardiac disease:
- Myocardial infarction or unstable angina pectoris within 6 months of enrollment.
- History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation.
- New York Heart Association (NYHA) class III or greater congestive heart failure or left ventricular ejection fraction of < 40%.
- Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months prior to the first dose of study drug.
- Patients with active chronic inflammatory bowel disease (ulcerative colitis, Crohn disease) and patients with a history of gastrointestinal obstruction or perforation within 6 months of enrollment.
- Patient has uncontrolled hypertension or diabetes.
- Patient has radiotherapy or major surgery within 4 weeks prior to the first dose of study drug.
- Patients has received a live vaccine within 30 days, or antibiotics within one week prior to the first dose of study drug.
- Patient has had chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that is not completed 2 weeks prior to the first dose of study drug.
- Note: Patients participating in observational studies are eligible.
- Patient has previously received topoisomerase 1 inhibitors.
- Patient has known hypersensitivity to sacituzumab govitecan or to any excipient contained in the drug formulation.
- Patient has other underlying medical conditions that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned treatment and follow-up.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
Spain11 sites, 11 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona
A responsible person Designated by the sponsor, +34 93 434 44 12, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.; Ph.D.
- Not yet recruiting
Complexo Hospitalario Universitario de Ferrol
Ferrol
A responsible person Designated by the sponsor, +34 93 434 44 12, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.; Ph.D.
- Recruiting
Institut Catala d´Oncologia (ICO) -Hospitalet
Hospitalet de Llobregat (Barcelona)
A responsible person Designated by the sponsor, +34 93 434 44 12, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.; Ph.D.
- Recruiting
Hospital Clínico San Carlos
Madrid
A responsible person Designated by the sponsor, +34 93 434 44 12, investigacion@mfar.net
A Principal Investigator Desingated by the sponsor, M.D.; Ph.D.
- Recruiting
Hospital Universitario la Paz
Madrid
A responsible person Designated by the sponsor, +34 93 434 44 12, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.; Ph.D.
- Not yet recruiting
Hospital Universitario Ramón y Cajal
Madrid
A responsible person Designated by the sponsor, +34 93 434 44 12, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.; Ph.D.
- Recruiting
MD Anderson Cancer Center Madrid
Madrid
A responsible person Designated by the sponsor, +34 93 434 44 12, investigacion@mfar.net
A principal investigator Designated by the sponsor, M.D.; Ph.D.
- Recruiting
Hospital General Universitario Morales Meseguer
Murcia
A responsible person Designated by the sponsor, +34 93 434 44 12, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.; Ph.D.
- Recruiting
Hospital Universitario Central de Asturias
Oviedo
A responsible person Designated by the sponsor, +34 93 434 44 12, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.; Ph.D.
- Recruiting
H.U. Marqués de Valdecilla
Santander
A responsible person Designated by the sponsor, +34 93 434 44 12, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.; Ph.D.
- Recruiting
Hospital Universitario Miguel Servet
Zaragoza
A responsible person Designated by the sponsor, +34 93 434 44 12, investigacion@mfar.net
A Principal Investigator Designated by the sponsor, M.D.; Ph.D.
About this study
Official title: A Multicenter, Open Label, Two Cohort, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of the Anti-TROP2 Antibody-drug Conjugate Sacituzumab Govitecan in Patients With Advanced Differentiated and Anaplastic Thyroid Neoplasms.
SETHY is a prospective, multicohort, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study of sacituzumab govitecan in patients with advanced or metastatic radioactive-iodine refractory differentiated thyroid carcinoma (DTC) or anaplastic thyroid carcinoma (ATC).
The main hypothesis is that treatment with sacituzumab govitecan, a anti-Trophoblast cell surface antigen 2 (TROP-2), could be an effective treatment option for patients with either differentiated and anaplastic thyroid neoplasms because TROP-2 is highly expressed at the membrane of DTC and ATC.
Read the detailed description
The trial will enroll competitively up to 21 patients per cohort. The study will enroll the first 12 patients within the cohort and monitor for response. If no confirmed response is documented the cohort will be closed. If there is one or more confirmed responses reported that cohort will be expanded up to the expected 21 patients. All patients, male or female, ≥ 18 years, with ECOG PS 0-1. Cohort 1 will include patients with advanced radioactive-iodine refractory DTC who progressed to previous TKIs (including but not limited to lenvatinib, sunitinib or cabozantinib) and cohort 2 will include patients with advanced or metastatic ATC who may be on first-line or progressed to a previous systemic treatment. Patients will have not received previously chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that are not completed 2 weeks before first dose of study treatment (See Section 6 for further detail on eligibility).
All enrolled patients will receive sacituzumab govitecan (10 mg/kg intravenously) on Days 1 and 8 of a 21-day cycle. Patients will be treated until progression, death, study withdrawal, or unacceptable toxicity. Sacituzumab govitecan is administered intravenously as a slow infusion as described below.
Dosing is based on the patient's body weight on Day 1 of each cycle (or at each dosing day if change in body weight is >10% or if required by institutional policy). Sacituzumab govitecan at 10 mg/kg will be the highest assigned dose. Dose reductions and delays will be allowed.
All patients will undergo periodic tumor assessments by CT or MRI scan every 12 weeks ± 14 days (3 months), and blood monitoring of tumor markers (i.e. thyroglobulin if applicable) every 12 weeks ± 3 days (3 months) from the start of study treatment until progression or patient withdrawal.
- Being tested
- Sacituzumab govitecan
- Keywords
- TROP-2, sacituzumab govitecan, Antibody-drug conjugate, SN-38
- Medical subject headings
- Thyroid Carcinoma, Anaplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab govitecanDrug
Also called Trodelvy
Dose of 10 mg/kg intravenously
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Sacituzumab govitecan (10 mg/kg) administered intravenously on Days 1 and 8 of a 21-day cycle. Patients will be treated until progression, death, study withdrawal, or unacceptable toxicity. Receives: Drug: Sacituzumab govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
percentage/proportion of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period. Objective responses will be assessed locally by the investigator according to RECIST, version 1.1
Measured: Throughout the study period, approximately 42 months since the inclusion of first patient
Secondary outcomes (6)
Disease control rate (DCR)
Percentage/proportion of patients with complete response (CR) or partial response (PR), according to ORR definition for the trial, or maintained stable disease (SD) as their overall best response, assessed by imaging follow-up (CT scan/MRI) and RECIST 1.1 criteria. Stable disease should be maintained for at least 4 months to be considered as a CBR event.
Measured: Throughout the study period, approximately 42 months since the inclusion of first patient
Duration of response (DoR)
Time from first confirmed response (CR or PR), according to ORR definition for the trial, to the date of the documented PD as determined using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.
Measured: Throughout the study period, approximately 42 months since the inclusion of first patient
Progression-free survival (PFS)
Time from first dosing date to the date of confirmed PD according to RECIST 1.1. Patients alive and free of events at the date of the analysis will be censored at their last known tumor assessment. Patients who start a new treatment line without progression will be censored on the date of first dose of the subsequent anticancer treatment.
Measured: Throughout the study period, approximately 42 months since the inclusion of first patient
Overall survival (OS)
Time elapsed from the first dose of study treatment until death from any cause. We will assess the median OS, estimated by Kaplan-Meier. Patients alive and free of events at the date of the analysis will be censored at their last known contact. Survival will be assessed by recording patient status at each visit. Long term follow up to be performed at least every 6 months.
Measured: Throughout the study period, approximately 42 months since the inclusion of first patient
Safety profile
Percentage/proportion of patients that experience adverse events classified by their type, severity and seriousness according to the National Cancer Institute's Common Toxicity criteria (NCI-CTCAE v5.0) scoring system.
Measured: Throughout the study period, approximately 42 months since the inclusion of first patient
Patient self-reported quality of life (QoL)
Assessed at baseline and every 12 weeks until progression through the EORTC QLQ-C30 questionnaire. The questionnaire is a validated tool composed of 30 questions or items that assess QoL in relation to physical, emotional, social aspects. The questionnaire is structured in 5 functional scales (physical functioning, daily activities, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, pain and nausea, vomiting), 1 global health status scale, and 6 independent items (dyspnea, insomnia, anorexia, constipation, diarrhea and economic impact). Values between 1 and 4 (1: not at all, 2: a little, 3: quite, 4: a lot) are assigned according to the patient's responses to the item, only in items 29 and 30 are they evaluated with a score of 1 to 7 (1: dreadful, 7: excellent). The scores obtained are standardized to 0-100.
Measured: Throughout the study period, approximately 42 months since the inclusion of first patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start13 Sep 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Differentiated Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- two cohorts of patients
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Espanol de Tumores Neuroendocrinos
- Sponsor type
- University, hospital or other
- Collaborators
- MFAR, Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Alejandro García-Alvarez, M.D.; Ph.D., Study chair, Hospital Universitario Vall d´HebronJaume Capdevila, M.D.; Ph.D., Study chair, Hospital Universitario Vall d´Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235216
- Sponsor's protocol ID
- GETNE T2318
- Other IDs
- 2023-504898-20, 2023
- Acronym
- SETHY
- Status last verified
- Sep 2026
- First submitted
- 23 Jan 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Provided upon reasonable request. All compiled or single patient data supporting the results will be publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Two Cohort, Single Arm, Phase II Study to Evaluate the Efficacy and Safety of the Anti-TROP2 Antibody-drug Conjugate Sacituzumab Govitecan in Patients With Advanced Differentiated and Anaplastic Thyroid Neoplasms.
- ClinicalTrials.gov ID
- NCT06235216
- Acronym / sponsor ID
- SETHY / GETNE T2318
- Keywords
- TROP-2, sacituzumab govitecan, Antibody-drug conjugate, SN-38
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Grupo Espanol de Tumores NeuroendocrinosUniversity, hospital or other
- Collaborators
- MFAR, Gilead Sciences
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SETHY is a prospective, multicohort, phase II, single-arm, non-randomized, non-blinded, investigator-initiated study of sacituzumab govitecan in patients with advanced or metastatic radioactive-iodine refractory differentiated thyroid carcinoma (DTC) or anaplastic thyroid carcinoma (ATC).
The main hypothesis is that treatment with sacituzumab govitecan, a anti-Trophoblast cell surface antigen 2 (TROP-2), could be an effective treatment option for patients with either differentiated and anaplastic thyroid neoplasms because TROP-2 is highly expressed at the membrane of DTC and ATC.
Detailed description
The trial will enroll competitively up to 21 patients per cohort. The study will enroll the first 12 patients within the cohort and monitor for response. If no confirmed response is documented the cohort will be closed. If there is one or more confirmed responses reported that cohort will be expanded up to the expected 21 patients. All patients, male or female, ≥ 18 years, with ECOG PS 0-1. Cohort 1 will include patients with advanced radioactive-iodine refractory DTC who progressed to previous TKIs (including but not limited to lenvatinib, sunitinib or cabozantinib) and cohort 2 will include patients with advanced or metastatic ATC who may be on first-line or progressed to a previous systemic treatment. Patients will have not received previously chemotherapy, biologics, investigational agents, and/or antitumor treatment with immunotherapy that are not completed 2 weeks before first dose of study treatment (See Section 6 for further detail on eligibility).
All enrolled patients will receive sacituzumab govitecan (10 mg/kg intravenously) on Days 1 and 8 of a 21-day cycle. Patients will be treated until progression, death, study withdrawal, or unacceptable toxicity. Sacituzumab govitecan is administered intravenously as a slow infusion as described below.
Dosing is based on the patient's body weight on Day 1 of each cycle (or at each dosing day if change in body weight is >10% or if required by institutional policy). Sacituzumab govitecan at 10 mg/kg will be the highest assigned dose. Dose reductions and delays will be allowed.
All patients will undergo periodic tumor assessments by CT or MRI scan every 12 weeks ± 14 days (3 months), and blood monitoring of tumor markers (i.e. thyroglobulin if applicable) every 12 weeks ± 3 days (3 months) from the start of study treatment until progression or patient withdrawal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- two cohorts of patients
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Sacituzumab govitecanSacituzumab govitecan (10 mg/kg) administered intravenously on Days 1 and 8 of a 21-day cycle. Patients will be treated until progression, death, study withdrawal, or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written informed consent.
- Patient is ≥ 18 years of age.
- Patient has histologically confirmed metastatic or locally advanced unresectable radioactive-iodine refractory differentiated thyroid cancer (cohort A) or anaplastic thyroid carcinoma (cohort B).
- Prior therapy in each cohort:
- Patient has radiographically documented and measurable metastatic or locally advanced disease at baseline.
Key exclusion criteria (24 listed)
- Patient has central nervous system (CNS) metastases.
- Patient has ongoing clinically significant toxicity (Grade 2 or higher with the exception of alopecia) associated with prior treatment (including systemic therapy, radiotherapy or surgery).
- Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Patient has a history of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy.
- Note: Patients with non melanoma skin cancer, curatively treated localized prostate cancer, or carcinoma in situ of any type (if complete resection was performed) are allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab govitecanAlso: TrodelvyDose of 10 mg/kg intravenously | Drug | Experimental |
Primary outcome
Objective response rate (ORR)
Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient
percentage/proportion of patients with confirmed complete response (CR) or partial response (PR) as their overall best response throughout the study period. Objective responses will be assessed locally by the investigator according to RECIST, version 1.1
6 secondary outcomes
Disease control rate (DCR)
Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient
Duration of response (DoR)
Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient
Progression-free survival (PFS)
Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient
Overall survival (OS)
Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient
Safety profile
Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient
Patient self-reported quality of life (QoL)
Time frame: Throughout the study period, approximately 42 months since the inclusion of first patient
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided. Provided upon reasonable request. All compiled or single patient data supporting the results will be publicly available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alejandro García-Alvarez, M.D.; Ph.D. study chair
Hospital Universitario Vall d´Hebron
Jaume Capdevila, M.D.; Ph.D. study chair
Hospital Universitario Vall d´Hebron
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab govitecan in people with Differentiated Thyroid Cancer and Anaplastic Thyroid Cancer, run by Grupo Espanol de Tumores Neuroendocrinos at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 28 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact A responsible person Designated by the Sponsor (+34 93 434 44 12, investigacion@mfar.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Throughout the study period, approximately 42 months since the inclusion of first patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.