Actively Recruiting
Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers
Led by M.D. Anderson Cancer Center · Updated on 2026-03-20
30
Participants Needed
1
Research Sites
261 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if sacituzumab govitecan can help to control salivary gland cancer.
CONDITIONS
Official Title
Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with confirmed recurrent or metastatic salivary gland cancer
- Disease not suitable for curative surgery or radiotherapy
- Measurable tumor according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Provided informed consent to participate
- Hemoglobin level at least 9 g/dL (transfusions allowed to meet this)
- Absolute neutrophil count at least 1 x 10^9/mL without growth factor support for 28 days
- Platelet count at least 100 x 10^9/mL without transfusion for 28 days
- Kidney function with creatinine clearance at least 30 mL/min
- Liver function with AST and ALT less than or equal to 2.5 times upper limit of normal (ULN) or up to 5 times ULN if liver metastases present
- Total bilirubin less than or equal to 1.5 times ULN, or up to 3.0 times ULN if Gilbert's syndrome or equivalent documented
- Female patients with reproductive potential must use two effective contraceptive methods during treatment and for 90 days after
- Male patients sexually active with women of reproductive potential must use contraception during treatment and for 90 days after
- Cohort 1: Patients with ACC who are treatment-naïve or have had any number of prior systemic therapies for recurrent/metastatic disease
- Cohort 1: Disease progression within 6 months by RECIST or clinical assessment
- Cohort 2: Patients with SDC, adenocarcinoma NOS, or MEC who progressed after up to 3 lines of chemotherapy for recurrent/metastatic disease
- Cohort 2: Patients with HER2 overexpressing tumors must have prior HER2-targeted therapy or a contraindication to it
You will not qualify if you...
- Radiation or other non-systemic therapy within 2 weeks before enrollment
- Active central nervous system disease, except stable treated lesions off therapy for 4 weeks
- Dependence on red blood cell transfusions (>2 units in 4 weeks before screening)
- Anticancer therapy including chemotherapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives before study treatment
- Participation in another interventional clinical study
- History of other malignancies except certain treated cancers with no active disease for at least 1 year
- Uncontrolled active infections requiring systemic therapy within 10 days before treatment
- Medical conditions increasing risk including recent heart attack, unstable angina, uncontrolled diabetes, severe infections, and severe heart failure
- Pregnancy or breastfeeding
- Known allergy to study drugs or their components
- Live virus vaccination within 30 days before treatment
- Use of high-dose systemic corticosteroids within 2 weeks before treatment
- Cognitive impairment preventing informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
R
Renata Ferrarotto, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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