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Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143
NCT04122625 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Debio 1143
Study Locations (17)
Other
- Centre Leon Berard — Lyon
- Institut Universitaire du Cancer de Toulouse Oncopole — Toulouse
- Institut Gustave Roussy — Villejuif
- Hospital Vall d'Hebron — Barcelona
- START Madrid, Fundacion Jimenez Diaz — Madrid
- START Madrid, H.U. Sanchinarro — Madrid
Florida
- University of Florida — Gainesville
- H. Lee Moffitt Cancer Center and Research Institute — Tampa
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
- Dana-Farber/Partners Cancer Care — Boston
Illinois
- Rush University Medical Center — Chicago
Missouri
- Washington University — St Louis
New York
- Montefiore Medical Center PRIME — The Bronx
Ohio
- UC Health, LLC. — Cincinnati
Pennsylvania
- St. Luke's University Health Network — Bethlehem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2019-04-26 |
| Est. Completion | 2022-04-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04122625
The ClinicalTrials.gov registry entry for NCT04122625 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debiopharm International, which has 41 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions — of which Nivolumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04122625 reports 17 study locations spanning 10 distinct geographic areas — top geographies include Other, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04122625 about?
NCT04122625 is a clinical study titled "Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143". 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 ...
What is the current status of trial NCT04122625?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2019-04-26. Estimated completion is 2022-04-06.
What conditions does trial NCT04122625 study?
This clinical trial studies the following conditions: Solid Tumor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04122625?
The interventions under investigation include: Nivolumab (DRUG), Debio 1143 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04122625?
This trial is sponsored by Debiopharm International, which has 41 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04122625 being conducted?
This trial has 17 study locations across Florida, Illinois, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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