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NCT05765812 · ClinicalTrials.gov registry record · Phase 1

A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma

A Phase 1 study of Astrocytoma, Grade III and Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, sponsored by Debiopharm International.

Recruiting
Registry status
Phase 1
Development phase
116
Enrollment target
17
Study locations

NCT05765812 is a Phase 1 study of Astrocytoma, Grade III and Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype that is actively recruiting participants, run by Debiopharm International. The registered enrollment target is 116 participants, below the 230-participant average among 4 other Astrocytoma, Grade III trials with a reported enrollment target (50% lower). The trial reports 17 study locations across 6 states.

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The verdict

NCT05765812, a Phase 1 study of Astrocytoma, Grade III and Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, is actively recruiting participants, sponsored by Debiopharm International.

RECRUITING
Registry status
Phase 1
Development phase
116 participants
Enrollment target
17
Study locations

Study Summary

The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of Debio 0123 combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the safety and tolerability of these combinations in adult participants with glioblastoma (GBM). Arm B which was previously added to the protocol, has been permanently halted per the safety monitoring committees' decision on the safety findings of this arm. The primary purpose of Phase 1 (Dose expansion) of the study is to assess the doses studied under Phase 1 (Dose Escalation) Arm A and identify the recommended dose (RD) for further development. The Phase 2 will start once the RD Phase 1 has been defined. The primary objective of Phase 2 is to assess the efficacy of Debio 0123 at the RD for further development in combination with TMZ, compared to the standard of care (SOC) in adult participants with GBM.

Conditions Studied

Astrocytoma, Grade III Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

Interventions

  • DRUG Temozolomide
  • RADIATION Radiotherapy
  • DRUG Debio 0123

Study Locations (17)

Other

  • Hospital Universitario Vall d'Hebron - Barcelona
  • Hospital Universitario Donostia - Donostia / San Sebastian
  • Clinica Universidad de Navarra (CUN) - Madrid
  • South Texas Accelerated Research Therapeutics (START) - Madrid
  • Hospital Universitario 12 de Octubre - Madrid
  • Clinica Universidad de Navarra (CUN) - Pamplona
  • Hospital Universitario Donostia - San Sebastián
  • Hospital Clinico Universitario de Valencia - Valencia
  • Universitaetsspital Zuerich - Zurich

Texas

  • Baylor Scott & White Research Institute - Dallas
  • The University of Texas MD Anderson Cancer Center - Houston
  • South Texas Accelerated Research Therapeutics (START) - San Antonio

New York

  • New York University Langone Medical Center - New York
  • David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center - New York

Illinois

  • Northwestern Memorial Hospital - Chicago

Utah

  • Huntsman Cancer Institute - Salt Lake City

Washington

  • Fred Hutchinson Cancer Research Center - Seattle

Trial Details

FieldValue
Enrollment Target 116 participants
Start Date 2023-05-15
Est. Completion 2028-09
Phase Phase 1

Sponsor

Debiopharm International

30 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05765812

The ClinicalTrials.gov registry entry for NCT05765812 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 230-participant average among 4 other Astrocytoma, Grade III trials with a reported enrollment target (50% lower). The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Astrocytoma, Grade III appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.

NCT05765812 reports 17 study locations spanning 6 distinct geographic areas - top geographies include Other, Texas, New York.

Frequently Asked Questions

What is clinical trial NCT05765812 about?

NCT05765812 is a clinical study titled "A Study of Debio 0123 in Combination With Temozolomide in Adult Participants With Recurrent or Progressive Glioblastoma and of Debio 0123 in Combination With Temozolomide and Radiotherapy in Adult Participants With Newly Diagnosed Glioblastoma". The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of Debio 0123 combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the safety and tolerability of these combinations in adul...

What is the current status of trial NCT05765812?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 116 participants. The study started on 2023-05-15. Estimated completion is 2028-09.

What conditions does trial NCT05765812 study?

This clinical trial studies the following conditions: Astrocytoma, Grade III, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype.

What interventions are being tested in trial NCT05765812?

The interventions under investigation include: Temozolomide (DRUG), Radiotherapy (RADIATION), Debio 0123 (DRUG).

Who is sponsoring clinical trial NCT05765812?

This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05765812 being conducted?

This trial has 17 study locations across Illinois, New York, Texas, Utah, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.