Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors
- Conditions
- Advanced Solid Tumors
- Registration Number
- NCT03968653
- Lead Sponsor
- Debiopharm International SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 115
Inclusion Criteria:<br><br>Dose Escalation:<br><br> - Histologically or cytologically confirmed locally advanced or metastatic solid and<br> nonbleeding tumors that had recurred or progressed following standard therapy, has<br> not responded to standard therapy or for which no standard therapy of proven benefit<br> is available<br><br> - Able and willing to undergo tumor biopsy<br><br> - Prior platinum-based therapy (carboplatin or cisplatin).<br><br> - Life expectancy of at least 3 months<br><br> - ECOG PS 0-1<br><br>Dose Expansion:<br><br> - Histologically or cytologically confirmed, recurrent solid tumors of selected types.<br><br> - Participants must have progressed after at least 1 prior platinum-based line of<br> therapy for advanced/metastatic disease.<br><br> - Participants must be platinum resistant (defined as progression within 6 months of<br> completion of their most recent platinum-based chemotherapy). Prior poly<br> (ADP-ribose) polymerase (PARP) inhibitor therapy is allowed. Platinum-based therapy<br> does not need to be the last treatment prior to study entry.<br><br> - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version<br> 1.1<br><br> - Documented progressive or recurrent disease according to RECIST 1.1 since the last<br> anti-cancer therapy and prior to study entry<br><br> - Able and willing to undergo tumor biopsy<br><br> - ECOG PS 0-1<br><br> - Life expectancy of at least 3 months<br><br>Exclusion Criteria:<br><br>Dose Escalation and Dose Expansion:<br><br> - History of other malignancies requiring active treatment in the last 6 months<br><br> - Brain tumors and/or symptomatic brain metastases<br><br> - Receiving other investigating agents<br><br> - Presence of significant cardiovascular disease or other co-morbidities such as<br> symptomatic ascites<br><br> - Prior exposure to any WEE1 inhibitor
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dose Escalation: Recommended Phase 2 Dose (RP2D) of Debio 0123 When Administered in Combination with Carboplatin;Dose Expansion: Percentage of Participants with Treatment-Emergent Serious Adverse Events (SAEs);Dose Expansion: Percentage of Participants with Treatment Discontinuations and Treatment Modifications Due to Adverse Events (AEs) and Laboratory Abnormalities;Dose Expansion: Overall Response Rate (ORR)
- Secondary Outcome Measures
Name Time Method