Actively Recruiting
Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC)
Led by National University Hospital, Singapore · Updated on 2025-07-25
32
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
Sponsors
N
National University Hospital, Singapore
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide written consent for the trial
- At least 21 years of age on the day of signing informed consent
- Histologically or cytologically confirmed advanced or unresectable salivary gland cancer or thyroid cancer not suitable for local treatment
- Have measurable disease based on RECIST 1.1 criteria
- For salivary gland cancer: metastatic or recurrent unresectable disease with progression in the last 6 months and at least 1 prior systemic treatment unless contraindicated or no standard care exists
- For thyroid cancer: unresectable metastatic or recurrent radioactive iodine refractory differentiated thyroid carcinoma with progression in the last 13 months and at least 1 prior tyrosine kinase inhibitor treatment unless contraindicated; if known RET alteration or NTRK fusion, must have received 2 prior TKIs unless contraindicated or declined second line
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function with specimens collected within 10 days before starting treatment
- Willingness to provide blood and tumor tissue samples for biomarker analysis
You will not qualify if you...
- Untreated brain metastases or leptomeningeal metastases
- Participation in another investigational study or use of investigational device within 4 weeks before first dose
- Received radiotherapy within 2 weeks before starting treatment and not fully recovered from related toxicities
- Known progressing additional malignancy requiring active treatment within the past 3 years
- Known severe allergy to sacituzumab govitecan
- Active infection requiring systemic treatment including tuberculosis
- Any condition or abnormality that may interfere with trial participation or results as judged by the investigator
- Psychiatric or substance abuse disorders interfering with cooperation
- Recent cardiovascular thromboembolic events within specified timeframes including chest pain, pulmonary embolism, myocardial infarction, heart failure, ventricular arrhythmia, or stroke
- Pregnant, breastfeeding, or planning pregnancy or fatherhood during the trial
- Positive pregnancy test within 72 hours before first dose for women of childbearing potential
- Unwillingness to use effective contraception during and after the study as specified
- Received live virus vaccination within 4 weeks before first dose
AI-Screening
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Trial Site Locations
Total: 1 location
1
National University Cancer Institute Singapore
Singapore, Singapore, 119074
Actively Recruiting
Research Team
W
Wan Qin Dr Chong, MD
CONTACT
B
Boon Cher Prof Goh, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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