Status:
COMPLETED
Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143
Lead Sponsor:
Debiopharm International SA
Conditions:
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 opt...
Eligibility Criteria
Inclusion
- Have received at least one prior line of standard systemic chemotherapy in the advanced/unresectable cancer setting (standard adjuvant/neoadjuvant treatment is acceptable if relapse occurred within six months of treatment end)
- Have progressed or relapsed during or after a prior anti-programmed cell death-1 (PD-1)/ programmed cell death-ligand 1 (PD-L1)-based treatment, given either as a single agent or in combination with standard/approved chemotherapy, tyrosine kinase inhibitors (TKIs), radiotherapy (RT) or other monoclonal antibodies (mAbs) that are not known to modulate/inhibit immune checkpoints (CPIs)
- Measurable disease (Part B only) according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) or Gynecologic Cancer Intergroup (GCIG) criteria in Cohort #4 of Part B (if applicable) and documented PD during or after prior PD-1/PD-L1 based therapy
Exclusion
- Thoracic or head and neck radiation \>30 gray (Gy) within the 3 months prior to Cycle 1 Day 1 (C1D1)
- Have received, in total, more than 3 (i.e., Cohorts 1 \& 2) or 4 (i.e., Cohorts 3 \& 4) lines of prior systemic treatments in Part B (including adjuvant or neoadjuvant regimens if relapse within six months prior to C1D1)
- Liver cirrhosis Child-Pugh score B or C
Key Trial Info
Start Date :
April 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04122625
Start Date
April 26 2019
End Date
April 6 2022
Last Update
June 12 2023
Active Locations (17)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Florida
Gainesville, Florida, United States, 32611
2
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215