Actively Recruiting
Sacituzumab govitEcan in THYroid Cancers
Led by Grupo Espanol de Tumores Neuroendocrinos · Updated on 2024-11-01
42
Participants Needed
11
Research Sites
167 weeks
Total Duration
On this page
Sponsors
G
Grupo Espanol de Tumores Neuroendocrinos
Lead Sponsor
M
MFAR
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sacituzumab govitEcan in THYroid Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has given written informed consent approved by the Institutional Review Board or Ethics Committee.
- Patient is 18 years of age or older.
- Patient has histologically confirmed metastatic or locally advanced unresectable radioactive-iodine refractory differentiated thyroid cancer or anaplastic thyroid carcinoma.
- Cohort A patients have progressed on at least one prior systemic therapy such as Sorafenib, Lenvatinib, or Cabozantinib, with up to 3 prior systemic treatments allowed.
- Cohort B patients are either treatment-naive or have failed up to one prior systemic treatment.
- Patient has measurable metastatic or locally advanced disease documented by imaging.
- An archival or new tumor tissue sample is available for laboratory studies.
- Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Baseline laboratory values meet specified minimums for neutrophils, platelets, hemoglobin, bilirubin, albumin, creatinine clearance, and liver enzymes.
- Female patients are either not of childbearing potential or agree to pregnancy prevention measures during and after the study.
- Female patients agree not to breastfeed or donate eggs during and after the study.
- Male patients agree not to donate sperm and to use contraception if their partner can bear children during and after the study.
- Patient agrees not to participate in another interventional study while receiving treatment in this trial.
You will not qualify if you...
- Patient has central nervous system (brain) metastases.
- Patient has ongoing significant toxicity (grade 2 or higher except alopecia) from prior treatments.
- Patient has had another malignancy within 3 years except certain treated cancers like non-melanoma skin cancer or localized prostate cancer.
- Patient has active Hepatitis B or C infection or HIV infection.
- Patient has recent serious cardiac events, severe heart failure, or serious arrhythmias.
- Patient has clinically significant active COPD or other moderate to severe chronic respiratory illness.
- Patient has active chronic inflammatory bowel disease or recent gastrointestinal obstruction or perforation.
- Patient has uncontrolled high blood pressure or diabetes.
- Patient has had recent radiotherapy or major surgery within 4 weeks prior to study drug.
- Patient has received live vaccines within 30 days or antibiotics within 1 week before study drug.
- Patient has recently received chemotherapy, biologics, investigational agents, or immunotherapy within 2 weeks before study drug.
- Patient has previously received topoisomerase 1 inhibitors.
- Patient has known allergy to sacituzumab govitecan or its ingredients.
- Patient has medical conditions that may impair ability to tolerate treatment and follow-up as judged by the investigator.
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Actively Recruiting
2
Complexo Hospitalario Universitario de Ferrol
Ferrol, Spain
Not Yet Recruiting
3
Institut Catala d´Oncologia (ICO) -Hospitalet
Hospitalet de Llobregat (Barcelona), Spain
Actively Recruiting
4
Hospital Clínico San Carlos
Madrid, Spain
Actively Recruiting
5
Hospital Universitario la Paz
Madrid, Spain
Actively Recruiting
6
Hospital Universitario Ramón y Cajal
Madrid, Spain
Not Yet Recruiting
7
MD Anderson Cancer Center Madrid
Madrid, Spain
Actively Recruiting
8
Hospital General Universitario Morales Meseguer
Murcia, Spain
Actively Recruiting
9
Hospital Universitario Central de Asturias
Oviedo, Spain
Actively Recruiting
10
H.U. Marqués de Valdecilla
Santander, Spain
Actively Recruiting
11
Hospital Universitario Miguel Servet
Zaragoza, Spain
Actively Recruiting
Research Team
A
A responsible person Designated by the Sponsor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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