Recruiting
Phase 1

Eflornithine & Temozolomide

Sponsor:

Orbus Therapeutics, Inc.

Code:

NCT05879367

Conditions

Glioblastoma, IDH-wildtype

Glioblastoma

Glioblastoma Multiforme

Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

GBM

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Eflornithine (Dose Level 1)

Eflornithine (Dose Level 2)

Eflornithine (Dose Level -1)

Temozolomide

Study Details

Brief summary:

The purpose of this study is to establish the recommended phase 2 dose of eflornithine in combination with temozolomide in patients whose glioblastoma or astrocytoma is newly diagnosed, and to evaluate safety and tolerability of this combination at that dose.

Conditions

Glioblastoma, IDH-wildtype

Glioblastoma

Glioblastoma Multiforme

Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

GBM

Study ID

NCT05879367

Start date

Jul 24, 2023

Status verified date

Jun, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of World Health Organization (WHO) G4 classified GBM, IDH-wildtype (patients with GBM) or G3 astrocytoma (IDH1 or 2 mutant; CDKN2A/B intact) per WHO 2021 tumor classification.
  • Completed external beam radiation therapy per standard of care.
  • Patients with GBM: Must have received at least 80% of planned daily doses of TMZ during chemoradiation. Patients with astrocytoma: Must have tolerated adjuvant TMZ treatment through at least 2 and not more than 4 cycles.
  • Adequate hematologic, renal, hepatic, and other organ function as indicated by hematology and serum chemistry testing.
  • Willing to abstain from intercourse or use acceptable contraceptive methods.
  • If taking corticosteroids, must be on a stable or decreasing dose.

Exclusion Criteria:

  • Recent history of recurrent or metastatic cancer that could confound response assessments
  • Prior systemic chemotherapy other than temozolomide during external beam radiation therapy (for patients with GBM) or adjuvant temozolomide through up to 4 pre-study cycles (for patients with astrocytoma).
  • Prior Optune treatment.
  • Active infection or serious intercurrent medical illness.
  • Poorly controlled seizures.
  • Significant cardiac disease within 6 months of enrollment.
  • Poorly controlled diabetes.
  • Use of another investigational agent within 30 days of enrollment.

Study Design

Enrollment

66 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eflornithine Dose Level 1 + Temozolomide

experimental: Eflornithine Dose Level 2 + Temozolomide

experimental: Eflornithine Dose Level -1 + Temozolomide

Interventions

Eflornithine (Dose Level 1)

Eflornithine 2.3 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

Eflornithine (Dose Level 2)

Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

Eflornithine (Dose Level -1)

Eflornithine 1.75 g/m2 administered orally every 8 hours on a 2 weeks on, 2 weeks off schedule

Temozolomide

Temozolomide 150 mg/m2 (with option to escalate per USPI maintenance phase instructions) administered orally once daily on a 5 days on, 23 days off schedule

Primary outcome measure

  • Assessment of Dose Limiting Toxicities [ Time Frame: 8 weeks ]
  • Incidence of TEAEs All Grades [ Time Frame: From enrollment to the follow-up visit 4 weeks after end of treatment ]
  • Incidence of TEAEs Grade 3+ [ Time Frame: From enrollment to the follow-up visit 4 weeks after end of treatment ]
  • Incidence of TEAEs Serious [ Time Frame: From enrollment to the follow-up visit 4 weeks after end of treatment ]
  • Incidence of TEAEs Leading to Discontinuation [ Time Frame: From enrollment to the end of treatment ]
  • Vital Signs (Heart and Respiratory Rate) [ Time Frame: From enrollment to the follow-up visit 4 weeks after end of treatment ]
  • Vital Signs (Blood Pressure) [ Time Frame: From enrollment to the follow-up visit 4 weeks after end of treatment ]
  • Incidence of Treatment-Emergent Abnormalities in Clinical Laboratory Tests [ Time Frame: From enrollment to the follow-up visit 4 weeks after end of treatment ]

Central Contacts and Locations

Central contacts

Monika Varga

6506569424monika.varga@orbustherapeutics.com

Locations

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Meghan Gauronskas

313-725-7871mgauron1@hfhs.org

Angela Dunn

313-725-7870adunn6@hfhs.org

Principal Investigator:

Tobias Walbert, MD, PhD, MPH

Columbia University Medical Center - Herbert Irving Pavilion

Recruiting

New York, New York, United States, 10032

Contacts

Maria Diaz, MD

212-342-0571md4157@cumc.columbia.edu

Nurse Navigators

212-342-5162cancerclinicaltrials@cumc.columbia.edu

Principal Investigator:

Maria Diaz, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Erin Severance

919-668-6230erin.k.bell@duke.edu

Principal Investigator:

Annick Desjardins, MD, FRCPC

The Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

David Peereboom, MD

216-445-6068peerebd@ccf.org

Rachel Hufsey, RN

hufseyr@ccf.org

Principal Investigator:

David Peereboom, MD

Brown University Health/Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Nuno Rodrigues, RN

401.444.3059Nuno.Rodrigues@brownhealth.org

Gada Alam

401-444-6217GAlam@brownhealth.org

Principal Investigator:

Eric Wong, MD

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Carlos Kamiya Matsuoka, MD

713-408-3538CKamiya@mdanderson.org

Evguenia Gachimova, RN

832-266-3519Egachimova@mdanderson.org

Principal Investigator:

Carlos Kamiya Matsuoka, MD

University of Utah, Huntsman Cancer Institute

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Rachel Kingsford

801-585-0115rachel.kingsford@hci.utah.edu

Yuri Kida

801-646-4397yuri.kida@hci.utah.edu

Principal Investigator:

Howard Colman, MD, PhD

More Information

Sponsor

Orbus Therapeutics, Inc.

Last update posted

Jun 25, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Orbus Therapeutics, Inc. on 2025-06-25.