Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Evaluate Safety and Preliminary Anti-tumor Activity of Debio 0123 as Monotherapy in Adult Participants With Advanced Solid Tumors
Sponsor: Debiopharm International SA
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.
Official title: A Phase 1, Dose-finding Study of Debio 0123 as Monotherapy in Adult Patients With Advanced Solid Tumors, Followed by an Expansion Part to Assess Safety and Preliminary Anti-tumor Activity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2021-11-05
Completion Date
2026-04
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
Debio 0123
Debio 0123 orally during 21-day treatment cycles.
Locations (16)
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Hospital Universitario de A Coruna
A Coruña, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Institut Catala de Oncologia
Girona, Spain
Clinica Universidad de Navarra
Madrid, Spain
START Madrid. Hospital Fundación Jimenez Diaz
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Clinica Universidad de Navarra
Pamplona, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Istituto Oncologico della Svizzera italiana - Ente Ospedaliero Cantonale
Bellinzona, Switzerland
Kantonsspital St. Gallen, Rorschacher Strasse 95
Sankt Gallen, Switzerland
Universitätsspital Zürich, Dermatologische Klinik
Zurich, Switzerland