Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC) - A Phase 2 Multi-centre 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.
• 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.
• Patients with metastatic or recurrent unresectable advanced salivary gland cancers must have progressive disease within the previous 6 months and have seen at least 1 prior line of systemic treatment, unless the patients had contraindications to the systemic treatment considered standard of care or there was no standard of care for that particular salivary gland histological subtype.
• Patients with unresectable metastatic or recurrent RAI refractory differentiated thyroid carcinoma, must have progressive disease within the previous 13 months and have seen at least 1 prior line of tyrosine kinase inhibitor (TKI), unless the patients had contraindications to the TKIs. Prior next generation sequencing is not mandated, but if known to harbour somatic pathogenic RET alteration or NTRK gene fusion, then the patient must have received 2 prior lines of TKIs, unless the patients had contraindications to the TKIs or declined the 2nd line of TKIs.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Have an adequate organ function. Specimens must be collected within 10 days prior to the start of study treatment.
• Provision of blood and tumour tissue samples (newly obtained biopsy if clinically feasible or archival specimen) to support exploratory biomarker analysis.