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ACTIVE NOT RECRUITING
NCT05109975
PHASE1

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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