Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors

NCT ID: NCT03968653

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-30
• Study Completion Date: 2025-10-23

Brief Summary

This study has two parts: Dose Escalation and Dose Expansion. The primary objective of the study, in the Dose Escalation Part is to determine the recommended phase 2 dose (RP2D) of Debio 0123 when administered in combination with carboplatin in participants with advanced solid tumors that recurred or progressed after prior cisplatin or carboplatin containing therapy and for which no standard therapy of proven benefit is available.

The primary objective of the study, in the Dose Expansion Part is to characterize the safety and tolerability of Debio 0123 when administered in combination with carboplatin at the RP2D determined during the dose escalation part of the study and to evaluate the preliminary antitumor activity of Debio 0123 when administered in combination with carboplatin.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation: Group A: Debio 0123

Participants will receive Debio 0123 as monotherapy (Day -3), orally, daily for 3 days during Cycle 1 then in combination with carboplatin intravenous infusion from Cycle 2 onwards.

Depending on pharmacokinetics (PK) and safety results from previous cohorts, the Debio 0123 dosing regimen may be modified for subsequent cohorts.

Group Type: EXPERIMENTAL

Debio 0123

Intervention Type: DRUG

Debio 0123 will be given as an oral capsule for 3 days during each 21-day cycle, except Cycle 1 which is of 24 days.

Carboplatin

Intervention Type: DRUG

Carboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 2 onwards in Group A.

Dose Escalation: Group B: Debio 0123

Participants will receive Debio 0123, orally, daily, for 6 days during each cycle in combination with carboplatin IV infusion.

Group Type: EXPERIMENTAL

Debio 0123

Intervention Type: DRUG

Debio 0123 will be given as an oral capsule for 3 or 6 days during each 21-day cycle.

Carboplatin

Intervention Type: DRUG

Carboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 1 onwards.

Dose Expansion: Debio 0123

Participants with platinum-resistant selected solid tumors will receive Debio 0123, orally, daily, depending on the RP2D determined in the previous part, for 3 or 6 days during each cycle in combination with carboplatin IV infusion.

Group Type: EXPERIMENTAL

Debio 0123

Intervention Type: DRUG

Debio 0123 will be given as an oral capsule for 3 or 6 days during each 21-day cycle.

Carboplatin

Intervention Type: DRUG

Carboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 1 onwards.

Interventions

Debio 0123

Debio 0123 will be given as an oral capsule for 3 days during each 21-day cycle, except Cycle 1 which is of 24 days.

Intervention Type: DRUG

Carboplatin

Carboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 2 onwards in Group A.

Intervention Type: DRUG

Debio 0123

Debio 0123 will be given as an oral capsule for 3 or 6 days during each 21-day cycle.

Intervention Type: DRUG

Carboplatin

Carboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 1 onwards.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Dose Escalation:

• Histologically or cytologically confirmed locally advanced or metastatic solid and nonbleeding tumors that had recurred or progressed following standard therapy, has not responded to standard therapy or for which no standard therapy of proven benefit is available
• Able and willing to undergo tumor biopsy
• Prior platinum-based therapy (carboplatin or cisplatin).
• Life expectancy of at least 3 months
• ECOG PS 0-1

Dose Expansion:

• Histologically or cytologically confirmed, recurrent solid tumors of selected types.
• Participants must have progressed after at least 1 prior platinum-based line of therapy for advanced/metastatic disease.
• Participants must be platinum resistant (defined as progression within 6 months of completion of their most recent platinum-based chemotherapy). Prior poly (ADP-ribose) polymerase (PARP) inhibitor therapy is allowed. Platinum-based therapy does not need to be the last treatment prior to study entry.
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
• Documented progressive or recurrent disease according to RECIST 1.1 since the last anti-cancer therapy and prior to study entry
• Able and willing to undergo tumor biopsy
• ECOG PS 0-1
• Life expectancy of at least 3 months

Exclusion Criteria

Dose Escalation and Dose Expansion:

• History of other malignancies requiring active treatment in the last 6 months
• Brain tumors and/or symptomatic brain metastases
• Receiving other investigating agents
• Presence of significant cardiovascular disease or other co-morbidities such as symptomatic ascites
• Prior exposure to any WEE1 inhibitor

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Debiopharm International SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Medical Center Groningen

Groningen, , Netherlands

Leiden University Medical Center, Dept. of Clinical Oncology

Leiden, , Netherlands

Radboud university medical center

Nijmegen, , Netherlands

Hospital Vall Hebrón, Unidad de Investigación en Terapia Molecular (UITM)

Barcelona, , Spain

Clinica Universidad de Navarra

Madrid, , Spain

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Clinica Universidad de Navarra - Pamplona

Pamplona, , Spain

Instituto Valenciano de Oncologia

Valencia, , Spain

Countries

Netherlands; Spain

Other Identifiers

2024-510984-52

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1302-8405

Identifier Type: OTHER

Identifier Source: secondary_id

Debio 0123-101

Identifier Type: -

Identifier Source: org_study_id