Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC)

Sponsor
National University Hospital, Singapore
Study ID
NCT06923826
Phase
PHASE2
Status
Recruiting
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Conditions

  • Salivary Gland Cancer
  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Sacituzumab govitecan — DRUG
    Day 1 and Day 8: Sacituzumab Govitecan will be administered at the dose of 10 mg/kg via intravenous infusion.

Study Details

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.

Key Dates

First listed
Apr 11, 2025
Start date
Apr 15, 2025
Status verified
Nov 2024
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
32 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Participants with metastatic/ recurrent salivary gland cancers such as adenoid cystic carcinoma, mucoepidermoid carcinoma, adenocarcinoma NOS and salivary duct carcinoma. Each treatment cycle is 3 weeks. Treatment will be continued till disease progression, unacceptable toxicity or withdrawal of consent
  • Experimental: Cohort B
    Participants with metastatic/ recurrent well-differentiated or poorly differentiated radioactive iodine (RAI) refractory thyroid carcinoma. Each treatment cycle is 3 weeks. Treatment will be continued till disease progression, unacceptable toxicity or withdrawal of consent.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: Up to 3 years ]

Central Contacts

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