Sacituzumab govitEcan in THYroid Cancers

NCT06235216 | Recruiting Phase 2 DMC

• 2 other identifiers: GETNE T23182023-504898-20
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 11

Brief 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). 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

Differentiated Thyroid Cancer; Anaplastic Thyroid Cancer

Keywords

TROP-2; sacituzumab govitecan; Antibody-drug conjugate; SN-38

Outcome Measures

Primary Outcomes (1)

• 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

  Throughout the study period, approximately 42 months since the inclusion of first patient

Secondary Outcomes (6)

• Disease control rate (DCR)

  Throughout the study period, approximately 42 months since the inclusion of first patient

• Duration of response (DoR)

  Throughout the study period, approximately 42 months since the inclusion of first patient

• Progression-free survival (PFS)

  Throughout the study period, approximately 42 months since the inclusion of first patient

• Overall survival (OS)

  Throughout the study period, approximately 42 months since the inclusion of first patient

• Safety profile

  Throughout the study period, approximately 42 months since the inclusion of first patient

Other Outcomes (1)

• TROP-2 positive rate

  Baseline

Study Arms (1)

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.

Drug: Sacituzumab govitecan

Interventions

Sacituzumab govitecan DRUG

Dose of 10 mg/kg intravenously

Also known as: Trodelvy

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Grupo Espanol de Tumores Neuroendocrinos: lead
• MFAR: collaborator
• Gilead Sciences: collaborator

Study Sites (11)

Hospital Universitari Vall d&#39;Hebron

Barcelona, Spain

RECRUITING

Complexo Hospitalario Universitario de Ferrol

Ferrol, Spain

NOT YET RECRUITING

Institut Catala d´Oncologia (ICO) -Hospitalet

Hospitalet de Llobregat (Barcelona), Spain

RECRUITING

Hospital Clínico San Carlos

Madrid, Spain

RECRUITING

Hospital Universitario la Paz

Madrid, Spain

RECRUITING

Hospital Universitario Ramón y Cajal

Madrid, Spain

NOT YET RECRUITING

MD Anderson Cancer Center Madrid

Madrid, Spain

RECRUITING

Hospital General Universitario Morales Meseguer

Murcia, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, Spain

RECRUITING

H.U. Marqués de Valdecilla

Santander, Spain

RECRUITING

Hospital Universitario Miguel Servet

Zaragoza, Spain

RECRUITING

MeSH Terms

Conditions

Thyroid Carcinoma, Anaplastic

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Alejandro García-Alvarez, M.D.; Ph.D.

  Hospital Universitario Vall d´Hebron

  STUDY CHAIR

• Jaume Capdevila, M.D.; Ph.D.

  Hospital Universitario Vall d´Hebron

  STUDY CHAIR

Central Study Contacts

A responsible person Designated by the Sponsor

CONTACT

+34 93 434 44 12; investigacion@mfar.net

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two cohorts of patients

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: January 31, 2024
• Study Start: September 13, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 1, 2024

Record last verified: 2024-10

Locations

ES (11)