Sacituzumab Govitecan for Recurrent Glioblastoma
This study is testing a treatment called Sacituzumab Govitecan for people with recurrent glioblastoma (a type of brain tumor) that has high levels of a protein called Trop-2. The study aims to see if Sacituzumab Govitecan helps people live longer compared to a past treatment called lomustine. You may be able to join if you are at least 18 years old and have a specific type of glioblastoma. All participants in this study will receive Sacituzumab Govitecan. The main goal is to measure how long people live after starting treatment, specifically at 6 months. The study is currently unclear about its recruitment status and plans to enroll 32 participants.
- Study design
- This is an open-label, single-arm study, meaning all 32 participants will receive the study drug, Sacituzumab Govitecan, and everyone involved will know which treatment is being given.
- What's involved
- You would participate for about 18 weeks, including a screening period, 3-week treatment periods of Sacituzumab Govitecan, and a final visit 3-4 weeks after your last dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- After your treatment ends, you or a family member will be contacted every 3 months for survival information until one year after your last dose of Sacituzumab Govitecan.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04559230
Sacituzumab Govitecan in Recurrent Glioblastoma
Recruiting
PHASE2Ages 18+InterventionalTreatmentThe University of Texas Health Science Center at San AntonioInvestigator-initiated
~32 participants
Updated 2026-03-30 on ClinicalTrials.gov
What's tested:Sacituzumab Govitecan
At a glance
Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall survival (OS)
Measured over 6 months
Conditions
Where it's being run
3 sites across 2 statesTexas2
Ohio1
Study leadership
- William Kelly, MD · PRINCIPAL_INVESTIGATOR · Mays Cancer Center, UT Health San Antonio
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Prior temozolomide is not required for MGMT unmethylated, but patient must have received standard doses of radiation.
Inclusion of additional investigational therapy with standard frontline therapy is not exclusionary. No additional lines of therapy given for recurrent disease.
Prior tumor-treating field therapy is not excluded, nor considered and additional line of therapy as this is often given concurrently with other therapy lines. 5. Patients may have had been operated for recurrence, but if operated must have had surgery a minimum of 2 weeks prior to enrollment and have an MRI completed within 48 hours following surgery. 6. No radiotherapy within the 3 months prior to the diagnosis of progression. 7. Willingness to forego tumor-treatment field (Optune) therapy during participation in the study. 8. Stable or decreasing dosage of steroids for 7 days prior to the baseline MRI scan. 9. Recovered from toxicities of prior therapy to grade 0 or 1, except for neuropathy (Grade ≤2) and alopecia. 10. ECOG performance status ≤ 2. 11. Life expectancy of at least 6 months. 12. Acceptable liver function:
Bilirubin ≤ 1.5 times upper limit of normal
AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN) 13. Acceptable renal function:
ANC ≥1500 cells/uL
Platelet count ≥100,000/uL
Hemoglobin ≥9.0 g/dL 15. All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose. 16. Availability of biological material for central review and biomarker evaluation. 17. Untreated recurrent or residual disease that is measurable by RANO criteria at time of enrollment. Multifocal and infratentorial disease is allowed. 18. Positive Trop-2 expression (H-Score ≥200), as verified by central review at University of Texas Health Science Center at San Antonio (UTHSA).
Exclusion
hypertension (two or more blood pressure \[BP\] readings performed at screening of \> 150 mmHg systolic or \> 100 mmHg diastolic) despite optimal treatment
non-healing wound, ulcer, or bone fracture
significant cardiac arrhythmias
untreated hypothyroidism
unhealed rectal or peri-rectal abscess
uncontrolled active infection
symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug
any history of cardiac arrhythmia or heart block
stroke or transient ischemic attack within 6 months 8. The subject has received any of the following prior anticancer therapy:
Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
Systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study drug
Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug
Prior treatment with carmustine wafers 9. Patients with radiographically or clinically apparent leptomeningeal involvement are excluded.
What this trial measures
- Overall survival (OS)6 months
Overall survival at 6 months including participants whose disease state has progressed