Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorNational University Hospital, Singapore
About this trial
The goal of this clinical trial is to learn if the drug, sacituzumab govitecan, works to treat:
1. Salivary gland cancers that have spread to other parts of the body or come back after previous treatment, and cannot be removed by surgery 2. A type of thyroid cancer (specifically, differentiated thyroid carcinoma) that has spread to other parts of the body or come back after previous treatment, no longer responds to radioactive iodine treatment and cannot be removed by surgery
The main question it aims to answer is whether sacituzumab govitecan can treat the 2 conditions mentioned above in a safe and effective manner.
Participants will:
* Receive sacituzumab govitecan by intravenous (IV) infusion on Day 1 and Day 8 of each treatment cycle. Each treatment cycle is 21 days (3 weeks) long. * Visit the clinic before each infusion for checkups and blood tests * Go through CT/PET/MRI scan once every 6 weeks for the first 24 weeks, then every 9 weeks thereafter. * Go through 2 tumour biopsies (if assessed by the doctor to be safe) at the start and at the end of study participation
Participants will continue to receive treatment with sacituzumab govitecan until their cancer stops responding to the drug or if they decide to withdraw from the study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participants (or legally acceptable representative if applicable) provide written consent for the trial.
At least 21 years of age on the day of signing informed consent.
Have histologically or cytologically confirmed diagnosis of advanced or unresectable salivary gland cancer or thyroid cancer, not amenable to local treatment.
Have measurable disease based on RECIST 1.1.
Disqualifiers
Has untreated brain metastases or leptomeningeal metastases.
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.
Has received prior radiotherapy within 2 weeks of the start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
Trial design
Design model
Parallel
Treatments tested in this trial
Sacituzumab govitecan
DrugDay 1 and Day 8: Sacituzumab Govitecan will be administered at the dose of 10 mg/kg via intravenous infusion.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Cohort AExperimental treatment 1 intervention
Group B: Cohort BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
ORR is defined as the as the percentage of participants with a complete response (CR) or partial response (PR) according to response evaluation criteria in solid tumours (RECIST) version 1.1.
Time frame
Up to 3 yearsSecondary outcomes
1
Progression free survival (PFS)
PFS is defined as the time from treatment assignment to disease progression or death, whichever occurs first
Time frame
From date of treatment assignment until first documented progression or date of death, whichever occurs earlier, assessed up to 3 years2
Incidence of Treatment-Related Adverse Events (TRAEs)
The frequency and outcome of TRAEs as assessed and graded according to the CTCAE version 5.0.
Time frame
From date of informed consent till 90 days following the date of last dose of study treatment.3
6-months Disease control rate (DCR)
6-months DCR is defined to be the percentage of participants with a complete response (CR), partial response (PR) or stable disease (SD) noted as the objective response status, according to RECIST version 1.1, at 6 months after initiating study treatment.
Time frame
Up to 6 months after initiating study treatment.4
Correlation of ORR with Trop-2 expression in tumour samples
Relationship between ORR and Trop-2 expression levels measured in tumour samples.
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National University Hospital, Singapore
Lead sponsor
Gilead Sciences
Collaborator
Source ClinicalTrials.gov