Sacituzumab govitEcan in THYroid Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGrupo Espanol de Tumores Neuroendocrinos
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
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.
Disqualifiers
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).
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.
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.
Trial design
Design model
Single group
Treatments tested in this trial
Sacituzumab govitecan
DrugDose of 10 mg/kg intravenously
Treatment groups
42 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Throughout the study period, approximately 42 months since the inclusion of first patientSecondary outcomes
1
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.
Time frame
Throughout the study period, approximately 42 months since the inclusion of first patient2
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.
Time frame
Throughout the study period, approximately 42 months since the inclusion of first patient3
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.
Time frame
Throughout the study period, approximately 42 months since the inclusion of first patient4
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.
Time frame
Throughout the study period, approximately 42 months since the inclusion of first patientOther outcomes
1
TROP-2 positive rate
Determined centrally on most recent archival tumor samples collected at baseline. Percentage/proportion of patients considered positive for the expression of TROP-2 gene. Strong complete membranous staining in \>5% of cells was considered positive.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov