Spots Global Cancer Trial Database for Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143
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Trial Identification
Brief Title: Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143
Official Title: A Dose-optimization, Exploratory Phase Ib/II 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-1/PD-L1 Treatment
Study ID: NCT04122625
Conditions
Study Description
Brief Summary: Part A (dose-optimization)- to determine the recommended phase 2 dose (RP2D) taking into account dose-limiting toxicity (DLT/s) in Cycle 1, overall safety/tolerability 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-high/mismatch repair deficiency (MSI-H/MMRd) 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 MSIH/MMRd, hereditary/somatic mutations of the breast cancer 1 (BRCA1) and BRCA2 genes or other DNA DDR abnormalities (incl. HRD).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Florida, Gainesville, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Rush University Medical Center, Chicago, Illinois, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Dana-Farber/Partners Cancer Care, Boston, Massachusetts, United States
Washington University, Saint Louis, Missouri, United States
Montefiore Medical Center PRIME, Bronx, New York, United States
UC Health, LLC., Cincinnati, Ohio, United States
St. Luke's University Health Network, Bethlehem, Pennsylvania, United States
Methodist Hospital, Houston Methodist Cancer Center, Houston, Texas, United States
Georgetown University - Lombardi Comprehensive Cancer Center, Northwest, Washington, United States
Centre Leon Berard, Lyon, , France
Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, , France
Institut Gustave Roussy, Villejuif, , France
Hospital Vall d'Hebron, Barcelona, , Spain
START Madrid, Fundacion Jimenez Diaz, Madrid, , Spain
START Madrid, H.U. Sanchinarro, Madrid, , Spain
Contact Details
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