TerminatedPhase 1

A Study to Evaluate Safety and Preliminary Anti-tumor Activity of Debio 0123 as Monotherapy in Adult Participants With Advanced Solid Tumors

Stopped: This trial was concluded for strategic reasons.

United States, Spain, Switzerland93 participantsStarted 2021-11-05

Plain-language summary

This study has two parts: Part 1 and Part 2. The purpose of this study in Part 1, Dose Escalation Part is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of Debio 0123 as monotherapy with repeated dosing in adults with advanced solid tumors that recurred or progressed after prior therapy and/or for whom no standard therapy of proven benefit is available. The purpose in Part 2, Expansion Part of this study, is to characterize the safety and tolerability of Debio 0123 in each study arm and overall when administered as monotherapy at the MTD/RP2D determined during the Dose Escalation Part 1 and to evaluate the preliminary anti-tumor activity of Debio 0123 when administered as monotherapy to participants in each study arm.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Part 1 dose escalation only: * Histologically or cytologically confirmed locally advanced or metastatic solid tumors. * Measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. * Disease progression under or following standard therapy and/or disease for which no available standard therapy of proven benefit. * Part 2 expansion only: * Measurable disease per RECIST version 1.1 criteria for each arm. * Participants (≥18 years old) who progressed or have recurrence of one of the tumor types specified in the study arms following standard therapy according to RECIST version 1.1, or for whom, in the opinion of the Investigator, no effective standard therapy exists. * Arm A: Histologically or cytologically confirmed USC that recurred or progressed following at least 1 prior platinum-based line of therapy for management of advanced or metastatic disease. * Arm B: Histologically or cytologically confirmed, recurrent, high-grade EOC, primary peritoneal cancer, or fallopian tube cancer with cyclin E1 driven selection. Participants must have progressed after at least 1 prior platinum-based therapy for advanced/metastatic disease. * Arm C: Histologically or cytologically confirmed, locally advanced or metastatic solid tumor with biomarker-driven selection. * Part 1 dose escalation and Part 2 expansion: * Accessible tumor for biopsy, and participant willing to undergo tumor biopsy unless …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial has been terminated early — can you find out why it was stopped, and what that means for the safety or effectiveness data that was collected on Debio 0123?
2Since this was a Phase 1 trial focused on finding a safe dose rather than proving the drug works, what do we actually know so far about whether Debio 0123 showed any anti-tumor activity in people with advanced solid tumors like mine?
3The trial was measuring serious adverse events and treatment discontinuations due to side effects — based on whatever data exists, what kinds of safety concerns showed up that I should be aware of?
4Given that this trial is no longer enrolling, are there other active trials studying Debio 0123 or similar WEE1 inhibitor drugs that might be worth looking into for my situation?
5Would standard treatment options for my specific type of advanced solid tumor make more sense to pursue first, before considering an experimental drug whose Phase 1 testing was cut short?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Maximum Tolerated Dose (MTD) as Determined by Percentage of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Cycle 1 (each cycle is 21 days)

Part 1: Recommended Phase 2 Dose (RP2D) as Determined by Percentage of Participants with DLTs and Cumulative Safety Data

Timeframe: Cycle 1 (each cycle is 21 days)

Part 2: Percentage of Participants with Serious Adverse Events (SAEs)

Timeframe: Up to 30 days after the last dose of study treatment (up to 13 months)

Part 2: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Laboratory Abnormalities

Timeframe: Up to 30 days after the last dose of study treatment (up to 13 months)

Part 2: Percentage of Participants with Treatment Discontinuations and Treatment Modifications due to Adverse Events (AEs) and Laboratory Abnormalities

Timeframe: Up to end of study treatment (up to 12 months)

Part 2: Overall Response Rate (ORR)

Timeframe: From the start of study treatment until disease progression (up to 12 months)

Trial details

NCT IDNCT05109975

SponsorDebiopharm International SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-04-24

View on ClinicalTrials.gov More Advanced Solid Tumors trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1: Maximum Tolerated Dose (MTD) as Determined by Percentage of Participants with Dose Limiting Toxicities (DLTs)

Timeframe: Cycle 1 (each cycle is 21 days)

Part 1: Recommended Phase 2 Dose (RP2D) as Determined by Percentage of Participants with DLTs and Cumulative Safety Data

Timeframe: Cycle 1 (each cycle is 21 days)

Part 2: Percentage of Participants with Serious Adverse Events (SAEs)

Timeframe: Up to 30 days after the last dose of study treatment (up to 13 months)

Part 2: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Laboratory Abnormalities

Timeframe: Up to 30 days after the last dose of study treatment (up to 13 months)

Part 2: Percentage of Participants with Treatment Discontinuations and Treatment Modifications due to Adverse Events (AEs) and Laboratory Abnormalities

Timeframe: Up to end of study treatment (up to 12 months)

Part 2: Overall Response Rate (ORR)

Timeframe: From the start of study treatment until disease progression (up to 12 months)