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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
93
Debio 0123 orally during 21-day treatment cycles.
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 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
...and 5 more locations
Part 1: Maximum Tolerated Dose (MTD) as Determined by Percentage of Participants with Dose Limiting Toxicities (DLTs)
Time frame: Cycle 1 (each cycle is 21 days)
Part 1: Recommended Phase 2 Dose (RP2D) as Determined by Percentage of Participants with DLTs and Cumulative Safety Data
Time frame: Cycle 1 (each cycle is 21 days)
Part 2: Percentage of Participants with Serious Adverse Events (SAEs)
Time frame: Up to 30 days after the last dose of study treatment (up to 13 months)
Part 2: Percentage of Participants with Treatment-Emergent Adverse Events (TEAEs) and Laboratory Abnormalities
Time frame: Up to 30 days after the last dose of study treatment (up to 13 months)
Part 2: Percentage of Participants with Treatment Discontinuations and Treatment Modifications due to Adverse Events (AEs) and Laboratory Abnormalities
Time frame: Up to end of study treatment (up to 12 months)
Part 2: Overall Response Rate (ORR)
Time frame: From the start of study treatment until disease progression (up to 12 months)
Part 1: Percentage of Participants with SAEs
Time frame: Up to 30 days after the last dose of study treatment (up to 13 months)
Part 1: Percentage of Participants with TEAEs and Laboratory Abnormalities
Time frame: Up to 30 days after the last dose of study treatment (up to 13 months)
Part 1: Plasma Concentration of Debio 0123
The pharmacokinetics (PK) of Debio-0123 will be evaluated in plasma.
Time frame: Pre-dose and at multiple time points up to 8 hours (h) on Day 1, Cycle 1 in Part 1 and 4 h on Day 1, Cycle 1 in Part 2 (each cycle is 21 days)
Parts 1 and 2: Anti-Tumor Activity as Assessed by Percentage of Participants with Tumor Response
Time frame: Parts 1 and 2: Up to 12 months
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