NCT03968653

Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors

A Phase 1 Study of Oral Debio 0123 in Combination With Carboplatin in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study has two parts: Dose Escalation and Dose Expansion. The primary objective of the study, in the Dose Escalation Part is to determine the recommended phase 2 dose (RP2D) of Debio 0123 when administered in combination with carboplatin in participants with advanced solid tumors that recurred or progressed after prior cisplatin or carboplatin containing therapy and for which no standard therapy of proven benefit is available. The primary objective of the study, in the Dose Expansion Part is to characterize the safety and tolerability of Debio 0123 when administered in combination with carboplatin at the RP2D determined during the dose escalation part of the study and to evaluate the preliminary antitumor activity of Debio 0123 when administered in combination with carboplatin.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	Debio 0123	Debio 0123 will be given as an oral capsule for 3 days during each 21-day cycle, except Cycle 1 which is of 24 days.
DRUG	Carboplatin	Carboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 2 onwards in Group A.
DRUG	Debio 0123	Debio 0123 will be given as an oral capsule for 3 or 6 days during each 21-day cycle.
DRUG	Carboplatin	Carboplatin will be given as an IV infusion in combination with Debio 0123 on Day 1 from Cycle 1 onwards.

Timeline

• Start date: 2019-07-30
• Primary completion: 2025-10-23
• Completion: 2025-10-23
• First posted: 2019-05-30
• Last updated: 2025-12-05

Locations

8 sites across 2 countries: Netherlands, Spain