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Recurrent GlioblastomaPhase 2NCT04559230

Sacituzumab Govitecan in Recurrent Glioblastoma

A Phase 2 study testing Sacituzumab Govitecan in people with Recurrent Glioblastoma, run by The University of Texas Health Science Center at San Antonio at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Glioblastoma
What is being tested?
Sacituzumab Govitecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
3 sitesUnited States
Study dates
6 Jan 2022to Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Inclusion of additional investigational therapy with standard frontline therapy is not exclusionary. No additional lines of therapy given for recurrent disease.
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  • 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
  • AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN)
  • Acceptable renal function:
  • Creatinine clearance ≥30 mL/minute according to the Cockcroft and Gault formula
  • Acceptable hematologic status (without hematologic support):
  • ANC ≥1500 cells/uL
  • Platelet count ≥100,000/uL
  • Hemoglobin ≥9.0 g/dL
  • 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.
  • Availability of biological material for central review and biomarker evaluation.
  • Untreated recurrent or residual disease that is measurable by RANO criteria at time of enrollment. Multifocal and infratentorial disease is allowed.
  • Positive Trop-2 expression (H-Score ≥200), as verified by central review at University of Texas Health Science Center at San Antonio (UTHSA).

Who cannot join

  • 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.
  • 3 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.
  • 4. 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).
  • 6. 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
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  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Epp Goodwin contact

210-450-1000

goodwine@uthscsa.edu

United States3 sites, 3 recruiting

  • Texas Oncology Austin

    Austin, Texas, 78705

    Brian Valliant, MD, (512) 421-4100, Brian.Vaillant@usoncology.com

    Brian Valliant, MD

    Recruiting

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44106

    Mina Lobbous, MD, MSPH, 216-445-3307, lobboum@ccf.org

    Mina Lobbous, MD

    Recruiting

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

    San Antonio, Texas, 78229

    William Kelly, MD, 210-450-1000, kellyw@uthscsa.edu

    Epp Goodwin, goodwine@uthscsa.edu

    Recruiting

Other trials in United States

About this study

Official title: A Phase II, Multicenter, Prospective Study of Sacituzumab Govitecan in Recurrent Glioblastoma

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.

Read the detailed description

Subjects are expected to participate for up to treatment duration with continued follow up for survival until one year after the last dose of study drug. The total duration of the active part of the study for each subject will be approximately 18 weeks, divided as follows:

  • Up to 3 weeks predose (screening period)
  • 3-week treatment periods of Sacituzumab govitecan
  • Study termination visit 3-4 weeks after last dose of study medication

When a subject has completed the study termination or early termination visit, he/she and/or a family member will be contacted for survival information every 3 months until one year from last study dose.

Being tested
Sacituzumab Govitecan
Keywords
Trophoblast Cell-Surface Antigen 2, Trop-2, Sacituzumab Govitecan
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab GovitecanDrug

    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.

Study groups in NCT04559230
Study groupRoleWhat they receive
Sacituzumab govitecanExperimentalDosing will be at 10 mg/kg on days 1 and 8 of a 21-day cycle
Receives: Drug: Sacituzumab Govitecan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival (OS)

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

    Measured: 6 months

Secondary outcomes (2)

  1. Progression free survival (PFS)

    To assess the progression-free survival (PFS) of these patients on SG vs historical control of lomustine monotherapy

    Measured: 6 months

  2. Overall Response Rate (ORR)

    To assess the Overall Response Rate (ORR) of these patients on SG by Response Assessment in Neuro-Oncology (RANO) criteria

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2020
  2. Study start6 Jan 2022
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04559230
Sponsor's protocol ID
CTMS# 20-0102
Other IDs
HSC20200576X
Status last verified
Jul 2025
First submitted
16 Sep 2020
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab Govitecan in people with Recurrent Glioblastoma, run by The University of Texas Health Science Center at San Antonio at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Epp Goodwin (210-450-1000, goodwine@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (OS) (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04559230.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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