NCT05884320

Brief Summary

To learn if sacituzumab govitecan can help to control salivary gland cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
27mo left

Started Jul 2023

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jul 2023Jul 2028

First Submitted

Initial submission to the registry

May 22, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 1, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 27, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

May 22, 2023

Last Update Submit

March 17, 2026

Conditions

GlandSalivary Gland Cancers

Outcome Measures

Primary Outcomes (1)

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    through study completion; an average of 2 years

Study Arms (2)

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.

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.

Drug: Sacituzumab Govitecan

Interventions

Sacituzumab GovitecanDRUG

Given by IV (vein)

Cohort 1: ACCCohort 2: Non-ACC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • 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.
  • +6 more criteria

You may not qualify if:

  • 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)
  • 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
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40624990DERIVED

Related Links

MeSH Terms

Conditions

Salivary Gland Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Mouth NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Study Officials

  • Renata Ferrarotto, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Renata Ferrarotto, MD

CONTACT

(713) 745-6774rferrarotto@mdanderson.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 1, 2023

Study Start

July 27, 2023

Primary Completion (Estimated)

July 31, 2028

Study Completion (Estimated)

July 31, 2028

Last Updated

March 20, 2026

Record last verified: 2026-03

Locations

US(1)