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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 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.

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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

Advanced Solid Tumors

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

FieldValue
Enrollment Target 66 participants
Start Date 2021-11-05
Est. Completion 2026-04
Phase Phase 1

Sponsor

Debiopharm International

30 total trials

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What the Registry Record Tells You About NCT05109975

The ClinicalTrials.gov registry entry for NCT05109975 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (67% lower). The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.

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 reports 16 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.