Sacituzumab Govitecan in Recurrent Glioblastoma

NCT04559230 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: CTMS# 20-0102HSC20200576X
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

This is an open-label single arm study. All patients will receive the study drug. The aim of the study is to compare overall survival (OS) of patients with recurrent brain tumor, known as Glioblastoma (GBM) having high levels of a protein, Trophoblast cell surface antigen 2 (Trop-2), expression on treatment with Sacituzumab Govitecan (SG) versus lomustine only which has been used in the past.

Conditions

Recurrent Glioblastoma

Keywords

Trophoblast Cell-Surface Antigen 2; Trop-2; Sacituzumab Govitecan

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  Overall survival at 6 months including participants whose disease state has progressed

  6 months

Secondary Outcomes (2)

• Progression free survival (PFS)

  6 months

• Overall Response Rate (ORR)

  6 week intervals for 6 months, then every 3 months until End of Treatment ( defined as evidence of significant treatment related toxicity or progressive disease)

Study Arms (1)

Sacituzumab govitecan

EXPERIMENTAL

Dosing will be at 10 mg/kg on days 1 and 8 of a 21-day cycle

Drug: Sacituzumab Govitecan

Interventions

Sacituzumab Govitecan DRUG

Sacituzumab Govitecan will be administered by IV infusion over 3 hours for first administration and over 1 hour if tolerated. Subjects will be allowed to continue treatment until they have evidence of significant treatment-related toxicity or progressive disease.

Sacituzumab govitecan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age.
• Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee.
• Histologically confirmed IDH wild type (primary) GBM. Molecular GBM (as per cIMPACT-NOW 3) is allowed as is gliosarcoma and epithelioid glioblastoma. IDH-mutant glioma is not allowed.
• Progression following standard combined modality treatment with radiation and temozolomide chemotherapy if O6-Methylguanine-DNA Methyltransferase (MGMT) methylated.
• Prior temozolomide is not required for MGMT unmethylated, but patient must have received standard doses of radiation.
• 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.
• 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.
• No radiotherapy within the 3 months prior to the diagnosis of progression.
• Willingness to forego tumor-treatment field (Optune) therapy during participation in the study.
• Stable or decreasing dosage of steroids for 7 days prior to the baseline MRI scan.
• Recovered from toxicities of prior therapy to grade 0 or 1, except for neuropathy (Grade ≤2) and alopecia.
• ECOG performance status ≤ 2.
• Life expectancy of at least 6 months.
• Acceptable liver function:
• Bilirubin ≤ 1.5 times upper limit of normal

You may not qualify if:

• Prior treatment with bevacizumab or other VEGF inhibitors or VEGF-Receptor signaling inhibitors
• The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
• The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage changes, punctate hemorrhage, or hemosiderin are eligible.
• \. The subject is unable to undergo MRI scan (eg, has pacemaker). 5. The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
• \. The subject is pregnant or breast-feeding. 7. The subject has serious intercurrent illness, such as:
• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (3)

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44106, United States

RECRUITING

Texas Oncology Austin

Austin, Texas, 78705, United States

RECRUITING

University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• William Kelly, MD

  Mays Cancer Center, UT Health San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Epp Goodwin

CONTACT

210-450-1000; goodwine@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: January 6, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)