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
Qualifiers
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
Treatments tested in this trial
- Sacituzumab govitecan
Treatment groups
Sponsors and collaborators
National University Hospital, Singapore
Lead sponsor
Gilead Sciences
Collaborator