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Debio 0123

DRUG6 trials

Sponsors

Debiopharm International S.A., Debiopharm International SA

Conditions

Advanced Solid TumorsAdvanced solid tumors with CCNE1 amplification or deleterious mutations in FBXW7 or other proprietary geneAstrocytoma, Grade IIIGlioblastomaGlioblastoma IDH (Isocitrate Dehydrogenase) WildtypeSmall Cell Lung Cancer Recurrent

Phase 1

Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors
TerminatedNCT03968653
Debiopharm International SAAdvanced Solid Tumors
Start: 2019-07-30End: 2025-10-23Updated: 2025-12-05
A Study to Evaluate Safety and Preliminary Anti-tumor Activity of Debio 0123 as Monotherapy in Adult Participants With Advanced Solid Tumors
Active, not recruitingNCT05109975
Debiopharm International SAAdvanced Solid Tumors
Start: 2021-11-05End: 2026-04-01Updated: 2026-03-30
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
RecruitingNCT05765812
Debiopharm International SAAstrocytoma, Grade III, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
Start: 2023-05-15End: 2028-09-01Target: 116Updated: 2026-03-30
Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy
Active, not recruitingNCT05815160
Debiopharm International SASmall Cell Lung Cancer Recurrent
Start: 2023-05-02End: 2026-03-01Updated: 2026-03-30
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
RecruitingCTIS2022-502156-31-00
Debiopharm International S.A.Glioblastoma
Start: 2023-05-26Target: 55Updated: 2025-11-03
Phase 1/1b Study of the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Clinical Activity of Lunresertib Alone or in Combination with RP-3500 or Debio 0123 in Patients with Advanced Solid Tumors (MYTHIC Study)
RecruitingCTIS2023-510063-35-00
Debiopharm International S.A.Advanced solid tumors with CCNE1 amplification or deleterious mutations in FBXW7 or other proprietary gene
Start: 2024-03-13Target: 38Updated: 2025-12-01

Related Papers

In silico evaluation of the interaction of P-gp and 3A4 substrates with the WEE1 inhibitor Debio 0123 and clinical application in the Debio 0123-104 combination trial with carboplatin and etoposide.
Journal of Clinical Oncology2025-05-28
Debio 0123, a highly selective WEE1 inhibitor, in combination with carboplatin (C) and etoposide (E), in patients (pts) with recurrent small cell lung cancer (SCLC): Determination of recommended dose (RD) from a phase 1 escalation.
Journal of Clinical Oncology2025-05-28
Debio 0123, a highly selective WEE1 inhibitor in adult patients with advanced solid tumors: A phase 1 dose escalation and expansion monotherapy study.
Journal of Clinical Oncology2025-05-28
A Phase II Trial of the WEE1 Inhibitor Adavosertib in <i>SETD2</i> <i>-</i> Altered Advanced Solid Tumor Malignancies (NCI 10170)
Cancer Research Communications2024-06-2611 citations
Results of a phase 1, dose-finding study of Debio 0123 as monotherapy in adult patients with advanced solid tumors: Safety, pharmacokinetic, and preliminary antitumor activity data.
Journal of Clinical Oncology2024-06-017 citations
Abstract CT064: Impact of food and high gastric pH on the bioavailability of the WEE1 inhibitor Debio 0123 assessed in a phase 1 dose escalation study
Cancer Research2024-04-05
RTID-03. A PHASE 1/2 STUDY OF THE WEE1 INHIBITOR DEBIO 0123 IN COMBINATION WITH TEMOZOLOMIDE +- RADIOTHERAPY IN ADULTS WITH RECURRENT OR NEWLY DIAGNOSED GLIOBLASTOMA
Neuro-Oncology2023-11-011 citations
Debio 0123-101: A phase 1 trial of Debio 0123 in combination with carboplatin in advanced solid tumors—Safety, pharmacokinetic, and preliminary antitumor activity data.
Journal of Clinical Oncology2023-06-0113 citations
A phase 1 dose-finding and dose-expansion study evaluating the safety, tolerability, pharmacokinetics, and efficacy of a highly selective WEE1 inhibitor (Debio 0123) in adult patients with advanced solid tumors.
Journal of Clinical Oncology2022-06-014 citations
601TiP First-in-human phase I study of a novel oral Wee1 inhibitor (Debio 0123) in combination with carboplatin in patients with advanced solid tumours
Annals of Oncology2020-09-015 citations