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New treatment option for Salivary Gland Cancer
Official title Sacituzumab Govitecan in Metastatic Salivary Gland and Thyroid Cancers (SG-SGTC)
ClinicalTrials.gov ID: NCT06923826
What this study is testing
What is Sacituzumab govitecan?
Sacituzumab govitecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for salivary gland cancer.
Also referred to as Trodelvy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- Has received prior radiotherapy within 2 weeks of the start of study treatment. Participants must have recovered from all radiation-related...
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Known severe hypersensitivity reaction to Sacituzumab govitecan.
- Has an active infection requiring systemic treatment. This includes TB (Bacillus Tuberculosis).
See the full eligibility criteria
- 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 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...
- 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.
- 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.
- Known severe hypersensitivity reaction to Sacituzumab govitecan.
- Has an active infection requiring systemic treatment. This includes TB (Bacillus Tuberculosis).
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is...
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Recent cardiovascular thromboembolic event, such as the following:
- Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 4 weeks before enrolment
- Symptomatic pulmonary embolism ≤ 4 weeks before enrolment
- Any history of acute myocardial infarction ≤ 6 months before enrolment
- Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV ≤ 6 months before enrolment
- Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before enrolment
- Any history of cerebrovascular accident ≤ 6 months before enrolment
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to first dose. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Note: In the event that 72...
- Is not willing to practice contraception during the study, and for up to a period of at least 6 months after the last dose of SG:
- A woman of childbearing potential who does not agree to follow the contraceptive guidance on the use of effective contraception during the treatment period and for at least 6 months after the last dose of study...
- A male participant who does not agree to the use of effective contraception during the treatment period and for at least 3 months after the last dose of study treatment, and to refrain from donating sperm during this...
- History of having received a live virus vaccination (e.g., yellow fever, MMR, nasal flu, chicken pox or Zostavax) within 4 weeks prior to the first dose of trial treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.