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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Debiopharm International SA
Study ID
NCT05765812
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Astrocytoma, Grade III
  • Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Debio 0123 — DRUG
    Administered as capsules.
  • Temozolomide — DRUG
    Administered as capsules.
  • Radiotherapy — RADIATION
    Administered in accordance with the local clinical practice and applicable Radiation Therapy Oncology Group (RTOG) or the European Organization for Research and Treatment of Cancer (EORTC) guidelines.

Study Details

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.

Key Dates

Start date
May 15, 2023
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (Dose Escalation): Arm A - Debio 0123 + Temozolomide
    Participants will receive intermittent Debio 0123, escalating doses along with temozolomide (TMZ) in each 28-day cycle for up to 2 years.
  • Experimental: Phase 1 (Dose Escalation): Arm B - Debio 0123 + Temozolomide + Radiotherapy
    Participants will receive intermittent Debio 0123, escalating doses along with TMZ and concomitant administration of radiotherapy (RT) for up to 6 weeks. As per Protocol \_V4.0 Arm B has been permanently halted.
  • Experimental: Phase 1 (Dose Escalation): Arm C - Debio 0123 + Temozolomide + Radiotherapy
    Participants will receive intermittent Debio 0123, escalating doses along with TMZ and concomitant administration of radiotherapy (RT) for up to 6 weeks.
  • Experimental: Phase 1 (Dose Expansion): Debio 0123 + Temozolomide
    Participants will receive Debio 0123, escalating doses along with temozolomide (TMZ) in each 28-day cycle for up to 2 years. Participants will receive one of the 2 selected doses for further investigation.
  • Experimental: Phase 2: Debio 0123 RD + Temozolomide
    Participants will receive intermittent Debio 0123 RD along with TMZ in each 28-day cycle for up to 2 years.

Primary Outcome Measure

Phase 1 (Dose Escalation): Number of Participants Experiencing Dose-limiting Toxicities (DLTs) [ Time Frame: Phase 1: Arm A: Cycle 1 (Cycle=28 days); Arms B and C: Up to approximately 1.8 months ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611-
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterNew YorkNew York10021-
New York University Langone Medical CenterNew YorkNew York10016-
Baylor Scott & White Research InstituteDallasTexas75246-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
South Texas Accelerated Research Therapeutics (START)San AntonioTexas78229-
Huntsman Cancer InstituteSalt Lake CityUtah84112-
Fred Hutchinson Cancer Research CenterSeattleWashington98109-

Find similar trials in Chicago, IL

By research site
Northwestern Memorial Hospital· Chicago, ILDavid H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center· New York, NYNew York University Langone Medical Center· New York, NYBaylor Scott & White Research Institute· Dallas, TXThe University of Texas MD Anderson Cancer Center· Houston, TXSouth Texas Accelerated Research Therapeutics (START)· San Antonio, TX

Related Studies