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New treatment option for Gland
Official title Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers
ClinicalTrials.gov ID: NCT05884320
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 gland.
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
- To learn if sacituzumab govitecan can help to control salivary gland cancer.
- 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 18 and older
You may be able to join if
- All patients must meet all of the following to be eligible for participation in this study:
- Patients ≥18 years with histology-proven R/M salivary gland cancer.
- Not amenable to curative intent surgery or radiotherapy
- Measurable disease per RECIST 1.1
- Performance status ECOG of 0 or 1
You likely can't join if
- Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this study:
- Prior radiation therapy (or other non-systemic therapy) within 2 weeks prior to enrollment
- Active CNS disease (patients with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed...
- Red blood cell transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening...
- Prior anticancer therapy including, but not limited to, chemotherapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives prior...
- Current participation in another treatment clinical study
See the full eligibility criteria
- All patients must meet all of the following to be eligible for participation in this study:
- Patients ≥18 years with histology-proven R/M salivary gland cancer.
- Not amenable to curative intent surgery or radiotherapy
- Measurable disease per RECIST 1.1
- Performance status ECOG of 0 or 1
- Patient has provided informed consent.
- Laboratory measurements, blood counts:
- Hemoglobin ≥ 9 g/dL. Red blood cell transfusions are permitted to meet the hemoglobin 2. Absolute neutrophil count ≥ 1 x 10\^9/mL without growth factor support for 28 days
- Platelets ≥ 100 x 10\^9/mL without platelet transfusion for 28 days
- Laboratory measurements, renal function: Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation
- Laboratory measurements, hepatic function:
- AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases
- Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN and primarily unconjugated if patient has a documented history of Gilbert's syndrome or genetic equivalent
- Female patients with reproductive potential must practice two effective contraceptive measures for the duration of study drug therapy and for at least 90 days after completion of study therapy. The two birth control...
- Male patients who are sexually active with women with reproductive potential must agree to use contraception for the duration of treatment and for at least 90 days after completion of study therapy. Cohort 1: In...
- Patients with histology-proven R/M ACC who are treatment-naïve or received any number of prior systemic therapy in the setting of R/M disease.
- Disease progression per RECIST within 6 months or unequivocal clinical progression within 6 months per investigator's assessment. Cohort 2: In addition to meeting the for all patients, patients who are enrolled into...
- 13) Patients with histology-proven R/M SDC or intermediate or high-grade adenocarcinoma NOS, or intermediate or high grade MEC, who progressed on up to 3 lines of palliative chemotherapy in the R/M setting. Any number...
- Patients with HER2 overexpressing (3+ by IHC) or amplified tumors, must have received at least one prior line with a HER2-targeting agent OR must have a contra-indication for HER-2 targeted therapy (Eg: reduced left...
- Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this study:
- Prior radiation therapy (or other non-systemic therapy) within 2 weeks prior to enrollment
- Active CNS disease (patients with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active)
- Red blood cell transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. Red blood cell transfusions are permitted during the screening period...
- Prior anticancer therapy including, but not limited to, chemotherapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives prior to SG treatment
- Current participation in another treatment clinical study
- History of previous malignancy other than malignancy treated with curative intent. Patients with the following diagnoses represents an exception and may enroll if ≥ 1 year with no evidence of active disease before the...
- Non-melanoma skin cancers with no current evidence of disease
- Melanoma in situ with no current evidence of disease
- Localized cancer of the prostate with prostate-specific antigen of \<1 ng/mL
- Treated or localized well-differentiated thyroid cancer
- Treated cervical carcinoma in situ
- Treated ductal/lobular carcinoma in situ of the breast
- Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 10 days prior to administration of investigational product. Patients with known hepatitis B, hepatitis C...
- Disease or medical conditions that would substantially increase the risk-benefit ratio of participating in the study that include: acute myocardial infarction within the last 6 months, unstable angina, uncontrolled...
- Female patients who are pregnant or breast-feeding
- Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient
- Received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
- High dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of study treatment (C1D1).
- Cognitively impaired patients who are incompetent to consent.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.