Loading clinical trials...

Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT05884320•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+11 more criteria

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
+9 more criteria

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

July 27, 2023

Primary Completion Date

July 31, 2028

Completion Date

July 31, 2028

Last Updated

March 20, 2026

Enrollment

ESTIMATED participants

Conditions

GlandSalivary Gland Cancers

Interventions

Sacituzumab Govitecan

DRUG

Contacts

Renata Ferrarotto, MD

CONTACT

(713) 745-6774 rferrarotto@mdanderson.org

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

View study

RECRUITING

Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer

NCT04742608

Thyroid Gland CarcinomaThyroid Gland Nodule

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Development of Liquid Biopsy Technologies for Noninvasive Cancer Diagnostics in Patients With Suspicious Thyroid Nodules or Thyroid Cancer

Intensity Modulated Proton or X-Ray Therapy After Surgery for Treatment of Head and Neck Cancer, the HEADLIGHT Study

Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection

A Study of AAV2-hAQP1 Gene Therapy in Participants With Radiation-Induced Late Xerostomia

[177Lu]Lu-AKIR001 First-in-human Study