Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04122625 · ClinicalTrials.gov registry record · Phase 1

Study to Assess Safety and Efficacy of the Second Mitochondrial-derived Activator of Caspases (SMAC) Mimetic Debio 1143

A Phase 1 study of Solid Tumor, sponsored by Debiopharm International.

Compiled by PlainTrial · August 8, 2026

Completed
Registry status: Phase 1
Development phase: 46
Enrollment target: 17
Study locations

NCT04122625: Completed Phase 1 study of Solid Tumor, sponsored by Debiopharm International.

NCT04122625 is a Phase 1 study of Solid Tumor that has completed, run by Debiopharm International. The registered enrollment target is 46 participants, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (79% lower). The trial reports 17 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04122625, a Phase 1 study of Solid Tumor, has completed, sponsored by Debiopharm International.

COMPLETED
Registry status: Phase 1
Development phase: 46 participants
Enrollment target: 17
Study locations

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).

Primary Outcome

DLT: any of following treatment-emergent adverse events (TEAEs) as per NCI CTCAE Grade V5.0 Criteria (Grades 1=mild, 2=moderate, 3=severe and 4 or 5= life-threatening/fatal outcomes) which are possibly, probably or definitely related to combination treatment and occurring in Cycle 1 (1 Cycle=28 days): Any Grade 4 or 5 hematologic toxicity, clinical or laboratory non-hematologic toxicity; febrile neutropenia any grade, Grade 3 thrombocytopenia if associated with bleeding or requiring platelet tra

Conditions Studied

Solid Tumor

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

Debiopharm International

30 total trials

What the finished NCT04122625 record still lists

NCT04122625 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (79% lower).

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.

NCT04122625 lists 17 locations in 10 states (Other, Florida, Massachusetts).

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.

What interventions are being tested in trial NCT04122625?

The interventions under investigation include: Nivolumab (DRUG), Debio 1143 (DRUG).

Who is sponsoring clinical trial NCT04122625?

This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04122625's enrollment target sits among peer trials

46 131st of 196 higher than 65 of 196 other Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

NCT01890590 · 46 participants · NA
A Phase II Study of Cyberknife Radiosurgery for Renal Cell Carcinoma
NCT03191149 · 46 participants · Phase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
NCT03510208 · 46 participants · Phase 1
Panitumumab-IRDye800 in Diagnosing Participants With Malignant Glioma Undergoing Surgery
NCT04048278 · 46 participants · Early Phase 1
Lidocaine Infusion in Pancreatic Cancer

Similar registry start date

NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT04122625, the US trial registry maintained by the National Library of Medicine. NCT04122625 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.