Clinical Trial TitleSMARTPLUS-106: Debio 1143 a SMAC mimetic in combination with nivolumab in patients failing prior PD-1/PD-L1 treatment: A basket trial.
National Clinical Trial Number:NCT03270176
Clinical Trial Protocol Description:
The purpose of this research study is to test an already-approved drug called nivolumab combined with an investigational study drug called Debio 1143. The study drug is an experimental drug. “Experimental” means that the study drug is currently being tested and is not approved for sale in the United States by the Food and Drug Administration (FDA). Debio 1143 is designed to promote the killing of cancer cells by blocking the activity of a proteins.
The study will focus on subjects with specific solid tumors for whom tumors were previously treated with anti-PD-1/PD-L1 therapy as a single therapy (or when used with other cancer therapies), but the tumors have worsened despite treatment. The study will also focus on subjects whose tumors have initially responded, but have stopped responding to treatment.
This is a Phase Ib/II study, which means that this study medication will be tested for the first time as a combination treatment in humans. This study is divided into two main parts, Part A and Part B. If you decide to take part in the study, the maximum study duration may be up to 7 years.
Clinical Trial Eligibility Criteria:
In order to participate in this study you must meet the following criteria:
- Are over 18 years of age.
- Have histologically and/or cytologically confirmed advanced/ unresectable or metastatic solid tumor.
- Have received at least one prior line of standard systemic chemotherapy in the advanced/unresectable cancer setting.
- Have adequate hematologic renal and hepatic function.
- Have available archived tumor samples for biomarker analysis obtained after prior PD-1/PD-L1 treatment failure, or if no samples available, patient must be suitable candidate for tumor biopsy.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.