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NCT05109975 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Safety and Preliminary Anti-tumor Activity of Debio 0123 as Monotherapy in Adult Participants With Advanced Solid Tumors
A Phase 1 study of Advanced Solid Tumors, sponsored by Debiopharm International.
- Active
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 16
- Study locations
NCT05109975: Active Phase 1 study of Advanced Solid Tumors, sponsored by Debiopharm International.
NCT05109975 is a Phase 1 study of Advanced Solid Tumors that is active but no longer recruiting, run by Debiopharm International. The registered enrollment target is 66 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (67% lower). The trial reports 16 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05109975, a Phase 1 study of Advanced Solid Tumors, is active but no longer recruiting, sponsored by Debiopharm International.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 16
- Study locations
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 |
What the registry record for NCT05109975 still lists
NCT05109975 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (67% lower).
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.
NCT05109975 lists 16 locations in 5 states (Other, Michigan, New York).
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.
What interventions are being tested in trial NCT05109975?
The interventions under investigation include: Debio 0123 (DRUG).
Who is sponsoring clinical trial NCT05109975?
This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05109975's enrollment target sits among peer trials
66 94th of 144 higher than 50 of 144 other Advanced Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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