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

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to determine the recommended phase 2 dose (RP2D) of Debio 0123 in combination with carboplatin in participants with advanced solid tumors that recurred or progressed after prior platinum based therapy and for which no standard therapy of proven benefit is available.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Debiopharm International SA
• Treatments: Carboplatin

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed locally advanced or metastatic solid and nonbleeding tumors that had recurred or progressed following standard therapy, has not responded to standard therapy or for which no standard therapy of proven benefit is available

• Able and willing to undergo tumor biopsy

• Prior platinum-based therapy (carboplatin or cisplatin).

• Life expectancy of at least 3 months

• ECOG performance score 0-1

Exclusion Criteria:

• History of other malignancies requiring active treatment in the last 6 months

• Brain tumors and/or symptomatic brain metastases

• Receiving other investigating agents

• Presence of significant cardiovascular disease or other co-morbidities such as symptomatic ascites