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.

Status: Recruiting
Location: See all (11) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

‣ 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:

• I) 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.

Locations
Other Locations
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Complexo Hospitalario Universitario de Ferrol
NOT_YET_RECRUITING
Ferrol
Institut Catala d´Oncologia (ICO) -Hospitalet
RECRUITING
Hospitalet De Llobregat (barcelona)
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario la Paz
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal
NOT_YET_RECRUITING
Madrid
MD Anderson Cancer Center Madrid
RECRUITING
Madrid
Hospital General Universitario Morales Meseguer
RECRUITING
Murcia
Hospital Universitario Central de Asturias
RECRUITING
Oviedo
H.U. Marqués de Valdecilla
RECRUITING
Santander
Hospital Universitario Miguel Servet
RECRUITING
Zaragoza
Contact Information
Primary
A responsible person Designated by the Sponsor
investigacion@mfar.net
+34 93 434 44 12
Time Frame
Start Date: 2024-09-13
Estimated Completion Date: 2027-12
Participants
Target number of participants: 42
Treatments
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.
Sponsors
Leads: Grupo Espanol de Tumores Neuroendocrinos
Collaborators: Gilead Sciences, MFAR

This content was sourced from clinicaltrials.gov