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A Study to Evaluate Safety and Preliminary Anti-tumor Activity of Debio 0123 as Monotherapy in Adult Participants With Advanced Solid Tumors
NCT05109975 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Debio 0123
Study Locations (16)
Other
- Hospital Universitario de A Coruna — A Coruña
- Hospital Universitari Vall d'Hebron — Barcelona
- Institut Catala de Oncologia — Girona
- Clinica Universidad de Navarra — Madrid
- START Madrid. Hospital Fundación Jimenez Diaz — Madrid
- Hospital Universitario 12 de Octubre — Madrid
- Hospital Universitario La Paz — Madrid
- Clinica Universidad de Navarra — Pamplona
- Hospital Clinico Universitario de Valencia — Valencia
- Istituto Oncologico della Svizzera italiana - Ente Ospedaliero Cantonale — Bellinzona
- Kantonsspital St. Gallen, Rorschacher Strasse 95 — Sankt Gallen
- Universitätsspital Zürich, Dermatologische Klinik — Zurich
Michigan
- South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids
New York
- David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center — New York
Texas
- South Texas Accelerated Research Therapeutics (START) — San Antonio
Wisconsin
- Froedtert Hospital and the Medical College of Wisconsin — Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2021-11-05 |
| Est. Completion | 2026-04 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05109975
The ClinicalTrials.gov registry entry for NCT05109975 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debiopharm International, which has 41 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention — of which Debio 0123 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05109975 reports 16 study locations spanning 5 distinct geographic areas — top geographies include Other, Michigan, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05109975 about?
NCT05109975 is a clinical study titled "A Study to Evaluate Safety and Preliminary Anti-tumor Activity of Debio 0123 as Monotherapy in Adult Participants With Advanced Solid Tumors". 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 p...
What is the current status of trial NCT05109975?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2021-11-05. Estimated completion is 2026-04.
What conditions does trial NCT05109975 study?
This clinical trial studies the following conditions: Advanced Solid Tumors. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05109975?
The interventions under investigation include: Debio 0123 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05109975?
This trial is sponsored by Debiopharm International, which has 41 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05109975 being conducted?
This trial has 16 study locations across Michigan, New York, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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