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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.

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

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.

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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).

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

FieldValue
Enrollment Target 46 participants
Start Date 2019-04-26
Est. Completion 2022-04-06
Phase Phase 1

Sponsor

Debiopharm International

30 total trials

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What the Registry Record Tells You About NCT04122625

The ClinicalTrials.gov registry entry for NCT04122625 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target (79% lower). The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.

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 reports 17 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.