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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Sacituzumab Govitecan

    Drug

    Given by IV (vein)

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Cohort 1: ACCExperimental treatment 1 intervention
Group B: Cohort 2: Non-ACCExperimental treatment 1 intervention

Trial outcomes

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

Time frame
through study completion; an average of 2 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Gilead Sciences

Collaborator