Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing Zedoresertib for Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of zedoresertib combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the whether it is safe and how hard side effects are to live with 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.

Official registry: https://clinicaltrials.gov/study/NCT05765812 · Debiopharm International SA · enrollment listed as 116

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Zedoresertib, Temozolomide, or Radiotherapy. The registry lists allocation as randomized. The primary purpose of the Phase 1 (Dose Escalation) of this study is to identify the dose-limiting toxicities (DLTs) of zedoresertib combined with temozolomide (TMZ) (Arm A) and with TMZ and radiotherapy (RT) (Arms B and C) and to characterize the whether it is safe and how hard side effects are to live with of these combinations in adult participants with glioblastoma (GBM).

They plan to enroll about 116 people at 16 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.

Official title (unrewritten)

A Phase 1/2 Open-label 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

Interventions: Zedoresertib, Temozolomide, Radiotherapy

Primary outcome (registry wording): Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Screening for Phase 1 and Phase 2:
  • Age ≥18 years of age
  • Willing to provide archived or fresh tumor sample, if available. Receipt of tumor sample is not required for the start of study treatment
  • Adequate bone marrow, hepatic, and renal function
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Willing to practice highly effective methods of contraception
  • Life expectancy of at least 3 months in the best judgment of the Investigator

Public study contact (from the registry)

Debiopharm International S.A

+41 21 321 01 11

clinicaltrials@debiopharm.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

16 listed

+ 8 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05765812 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05765812?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05765812?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary