Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers

NCT ID: NCT05884320

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-27
• Study Completion Date: 2028-07-31

Brief Summary

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

Conditions

Gland; Salivary Gland Cancers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: ACC

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.

Group Type: EXPERIMENTAL

Sacituzumab Govitecan

Intervention Type: DRUG

Given by IV (vein)

Cohort 2: Non-ACC

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.

Group Type: EXPERIMENTAL

Sacituzumab Govitecan

Intervention Type: DRUG

Given by IV (vein)

Interventions

Sacituzumab Govitecan

Given by IV (vein)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients ≥18 years with histology-proven R/M salivary gland cancer.

2. Not amenable to curative intent surgery or radiotherapy

3. Measurable disease per RECIST 1.1

4. Performance status ECOG of 0 or 1

5. Patient has provided informed consent.

6. Laboratory measurements, blood counts:

2. Absolute neutrophil count ≥ 1 x 10^9/mL without growth factor support for 28 days

3. Platelets ≥ 100 x 10^9/mL without platelet transfusion for 28 days

7. Laboratory measurements, renal function:

Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation

8. Laboratory measurements, hepatic function:

1. AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases

2. 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

9. 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).

10. 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:

11. 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.

12. Disease progression per RECIST within 6 months or unequivocal clinical progression within 6 months per investigator's assessment.

Cohort 2:

13. 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.

14. 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).

Exclusion Criteria

1. Prior radiation therapy (or other non-systemic therapy) within 2 weeks prior to enrollment

2. 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)

3. 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.

4. Prior anticancer therapy including, but not limited to, chemotherapy, immunotherapy, or investigational agents within 4 weeks or 5 half-lives prior to SG treatment

5. Current participation in another interventional clinical study

6. 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.:

1. Non-melanoma skin cancers with no current evidence of disease

2. Melanoma in situ with no current evidence of disease

3. Localized cancer of the prostate with prostate-specific antigen of <1 ng/mL

4. Treated or localized well-differentiated thyroid cancer

5. Treated cervical carcinoma in situ

6. Treated ductal/lobular carcinoma in situ of the breast

7. 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.

8. 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

9. Female patients who are pregnant or breast-feeding

10. Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient

11. Received a live-virus vaccination within 30 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.

12. High dose systemic corticosteroids (≥ 20 mg of prednisone or its equivalent) are not allowed within 2 weeks of study treatment (C1D1).

13. Cognitively impaired patients who are incompetent to consent.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renata Ferrarotto, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Renata Ferrarotto, MD

Role: CONTACT

rferrarotto@mdanderson.org

(713) 745-6774

Facility Contacts

Renata Ferrarotto, MD

Role: primary

rferrarotto@mdanderson.org

713-745-6774

References

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.

Reference Type: DERIVED

PMID: 40624990 (View on PubMed)

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2023-04260

Identifier Type: OTHER

Identifier Source: secondary_id

2022-0813

Identifier Type: -

Identifier Source: org_study_id