Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT04559230

Sacituzumab Govitecan in Recurrent Glioblastoma

Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-03-30

32

Participants Needed

3

Research Sites

316 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Sacituzumab Govitecan in Recurrent Glioblastoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age.
  • Able to understand study purposes and risks and provide written informed consent.
  • Histologically confirmed IDH wild type (primary) GBM, including molecular GBM, gliosarcoma, or epithelioid glioblastoma; IDH-mutant glioma excluded.
  • Progression after standard radiation and temozolomide if MGMT methylated; prior temozolomide not required if MGMT unmethylated but radiation required.
  • May have had surgery for recurrence at least 2 weeks before enrollment with MRI within 48 hours post-surgery.
  • No radiotherapy within 3 months before progression diagnosis.
  • Willing to stop tumor-treatment field (Optune) therapy during study.
  • Stable or decreasing steroid dose for 7 days before baseline MRI.
  • Recovered from prior therapy toxicities to grade 0 or 1 except neuropathy (up to grade 2) and alopecia.
  • ECOG performance status of 0, 1, or 2.
  • Life expectancy of at least 6 months.
  • Acceptable liver function (bilirubin ≤ 1.5 times ULN; AST and ALT ≤ 3 times ULN).
  • Acceptable kidney function (creatinine clearance ≥ 30 mL/min).
  • Acceptable blood counts without support (ANC ≥ 1500 cells/uL; platelets ≥ 100,000/uL; hemoglobin ≥ 9.0 g/dL).
  • Women of childbearing potential must have negative pregnancy test; all participants agree to effective contraception during and 6 months after study.
  • Availability of biological material for central review and biomarker evaluation.
  • Untreated recurrent or residual disease measurable by RANO criteria at enrollment; multifocal and infratentorial disease allowed.
  • Positive Trop-2 expression (H-Score ≥ 200) confirmed by central review.
Not Eligible

You will not qualify if you...

  • Prior treatment with bevacizumab or other VEGF or VEGF-Receptor inhibitors.
  • Currently receiving warfarin or similar anticoagulants and unable to switch to low molecular weight heparin before first study dose.
  • Evidence of acute intracranial or intratumoral hemorrhage by MRI or CT; resolving or minor hemorrhages allowed.
  • Unable to undergo MRI scan (e.g., pacemaker).
  • Use of enzyme-inducing anti-epileptic drugs within 14 days before study drug.
  • Pregnant or breastfeeding.
  • Serious illnesses such as uncontrolled hypertension, non-healing wounds, significant arrhythmias, untreated hypothyroidism, unhealed abscess, active infection, recent heart failure or unstable angina, history of arrhythmia or stroke.
  • Prior non-standard radiation therapies like brachytherapy or intra-operative radiotherapy; stereotactic radiosurgery allowed.
  • Recent systemic therapy or biologic agents within specified washout periods before study drug.
  • Prior treatment with carmustine wafers.
  • Radiographically or clinically evident leptomeningeal disease.

AI-Screening

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Trial Site Locations

Total: 3 locations

1

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

2

Texas Oncology Austin

Austin, Texas, United States, 78705

Actively Recruiting

3

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

San Antonio, Texas, United States, 78229

Actively Recruiting

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Research Team

E

Epp Goodwin

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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