GlandPhase 2NCT05884320
Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers
A Phase 2 study testing Sacituzumab Govitecan in people with Gland and Salivary Gland Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if sacituzumab govitecan can help to control salivary gland cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gland, Salivary Gland Cancers
- What is being tested?
- Sacituzumab Govitecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2023to 31 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients must meet all of the following inclusion criteria 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.
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- Laboratory measurements, blood counts:
- Hemoglobin ≥ 9 g/dL. Red blood cell transfusions are permitted to meet the hemoglobin inclusion criteria
- 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 methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom, copper intrauterine device, sponge, or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progesterone agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
- 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 addition to meeting the inclusion criteria for all patients, patients who are enrolled into Cohort 1 must fulfill the following cohort-specific inclusion criteria:
- 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 inclusion criteria for all patients, patients who are enrolled into Cohort 2 must fulfill the following cohort-specific inclusion criterion:
- 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 of prior targeted-therapy, hormonal therapy, and/or immunotherapy are allowed.
- 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 ventricular ejection fraction).
Who cannot join
- 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 and prior to enrollment to meet the hemoglobin inclusion criterion.
- 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 interventional clinical study
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- 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 first dose of the study drug.:
- 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 (HCV), or HIV infection could go on study provided the viral load is undetectable at screening.
- 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 diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
To learn if sacituzumab govitecan can help to control salivary gland cancer.
Read the detailed description
Primary Objectives:
- To assess the efficacy of SG in patients with R/M secretory gland carcinomas, specifically ACC (cohort 1) and SDC, adeno-NOS, and MEC (cohort 2)
Secondary Objectives:
- To estimate the median duration of response (DOR)
- To estimate the median progression-free survival (PFS)
- To estimate the median overall survival (OS)
- To assess safety of SG
Tertiary / Exploratory Objectives:
- To explore biomarkers that may predict response to therapy
- Conditions
- Gland, Salivary Gland Cancers
- Being tested
- Sacituzumab Govitecan
- Medical subject headings
- Salivary Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab GovitecanDrug
Given by IV (vein)
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: ACC | Experimental | Paritcipants will receive sacituzumab govitecan by vein on Days 1 and 8 of each cycle. The first dose will be given over about 3 hours. All other doses will be given over about 1-2 hours. Premedication for prevention of infusion reactions will be administered prior to each sacituzumab govitecan infusion. Receives: Drug: Sacituzumab Govitecan |
| Cohort 2: Non-ACC | Experimental | Paritcipants will receive sacituzumab govitecan by vein on Days 1 and 8 of each cycle. The first dose will be given over about 3 hours. All other doses will be given over about 1-2 hours. Premedication for prevention of infusion reactions will be administered prior to each sacituzumab govitecan infusion. Receives: Drug: Sacituzumab Govitecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start27 Jul 2023
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlandStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Renata Ferrarotto, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884320
- Sponsor's protocol ID
- 2022-0813
- Other IDs
- NCI-2023-04260
- Status last verified
- Nov 2026
- First submitted
- 22 May 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Siqueira JM, Mitani Y, Marques-Piubelli ML, Hoff CO, Bonini F, de Sousa LG, Mitani M, Carvalho GL, Nunes FD, Matos LL, Lin SY, Spiotto MT, Hanna EY, McGrail DJ, El-Naggar AK, Ferrarotto R. TROP2 Expression in Salivary Gland Adenoid Cystic Carcinoma (ACC) According to Histologic Subtype: Therapeutic Implications. J Oral Pathol Med. 2025 Sep;54(8):658-666. doi: 10.1111/jop.70008. Epub 2025 Jul 8.
PubMed 40624990
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers
- ClinicalTrials.gov ID
- NCT05884320
- Acronym / sponsor ID
- 2022-0813
- Conditions
- Gland, Salivary Gland Cancers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 63 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To learn if sacituzumab govitecan can help to control salivary gland cancer.
Detailed description
Primary Objectives:
- To assess the efficacy of SG in patients with R/M secretory gland carcinomas, specifically ACC (cohort 1) and SDC, adeno-NOS, and MEC (cohort 2)
Secondary Objectives:
- To estimate the median duration of response (DOR)
- To estimate the median progression-free survival (PFS)
- To estimate the median overall survival (OS)
- To assess safety of SG
Tertiary / Exploratory Objectives:
- To explore biomarkers that may predict response to therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: ACC | Experimental | Drug: Sacituzumab GovitecanParitcipants will receive sacituzumab govitecan by vein on Days 1 and 8 of each cycle. The first dose will be given over about 3 hours. All other doses will be given over about 1-2 hours. Premedication for prevention of infusion reactions will be administered prior to each sacituzumab govitecan infusion. |
| Cohort 2: Non-ACC | Experimental | Drug: Sacituzumab GovitecanParitcipants will receive sacituzumab govitecan by vein on Days 1 and 8 of each cycle. The first dose will be given over about 3 hours. All other doses will be given over about 1-2 hours. Premedication for prevention of infusion reactions will be administered prior to each sacituzumab govitecan infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- All patients must meet all of the following inclusion criteria 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
Key exclusion criteria (20 listed)
- 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 and prior to enrollment to meet the hemoglobin inclusion criterion.
- Prior anticancer therapy including, but not limited to, chemotherapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives prior to SG treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sacituzumab GovitecanGiven by IV (vein) | Drug | Cohort 1: ACC, Cohort 2: Non-ACC |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 40624990Siqueira JM, Mitani Y, Marques-Piubelli ML, Hoff CO, Bonini F, de Sousa LG, Mitani M, Carvalho GL, Nunes FD, Matos LL, Lin SY, Spiotto MT, Hanna EY, McGrail DJ, El-Naggar AK, Ferrarotto R. TROP2 Expression in Salivary Gland Adenoid Cystic Carcinoma (ACC) According to Histologic Subtype: Therapeutic Implications. J Oral Pathol Med. 2025 Sep;54(8):658-666. doi: 10.1111/jop.70008. Epub 2025 Jul 8.
- M D Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Ferrarotto, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sacituzumab Govitecan in people with Gland and Salivary Gland Cancers, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05884320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.