Ignite Creation Date:
2024-05-06 @ 1:48 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04122625
Status:
COMPLETED
Last Update Posted:
2023-06-12
First Post:
2019-08-30
Brief Title:
Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases SMAC Mimetic Debio 1143
Sponsor:
Debiopharm International SA
Organization:
Debiopharm International SA
Study Overview
Official Title:
A Dose-optimization Exploratory Phase IbII Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases SMAC Mimetic Debio 1143 When Given in Combination With the Anti-PD-1 Antibody Nivolumab in Patients With Specific Solid Tumors Who Have Progressed During or Immediately After Anti-PD-1PD-L1 Treatment
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SMARTPLUS-106
Brief Summary:
Part A dose-optimization- to determine the recommended phase 2 dose RP2D taking into account dose-limiting toxicity DLTs in Cycle 1 overall safetytolerability and pharmacokinetic PK by optimizing doses of Debio 1143 when combined with the standard dose of nivolumab as well as treatment compliance in participants with advanced solid malignancies who failed prior systemic standard treatments
Part B basket trial- to evaluate the preliminary anti-tumor activity of Debio 1143 at the RP2D in combination with nivolumab at the standard dose overall and in each participant cohort Cohort 1 small cell lung cancer SCLC Cohort 2 squamous cell carcinoma of the head and neck SCCHN Cohort 3 gastrointestinal GI cancers with known microsatellite instability-highmismatch repair deficiency MSI-HMMRd or other deoxyribonucleic acid DNA damage repair DDR abnormalities including homologous recombination deficiency HRD Cohort 4 platinum-resistant epithelial ovarian cancer EOC endometrial cancer primary peritoneal cancer PPC or cervical cancer with known MSIHMMRd hereditarysomatic mutations of the breast cancer 1 BRCA1 and BRCA2 genes or other DNA DDR abnormalities incl HRD
Part B basket trial- to evaluate the preliminary anti-tumor activity of Debio 1143 at the RP2D in combination with nivolumab at the standard dose overall and in each participant cohort Cohort 1 small cell lung cancer SCLC Cohort 2 squamous cell carcinoma of the head and neck SCCHN Cohort 3 gastrointestinal GI cancers with known microsatellite instability-highmismatch repair deficiency MSI-HMMRd or other deoxyribonucleic acid DNA damage repair DDR abnormalities including homologous recombination deficiency HRD Cohort 4 platinum-resistant epithelial ovarian cancer EOC endometrial cancer primary peritoneal cancer PPC or cervical cancer with known MSIHMMRd hereditarysomatic mutations of the breast cancer 1 BRCA1 and BRCA2 genes or other DNA DDR abnormalities incl HRD
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-003546-16 | EUDRACT_NUMBER | None | None |