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A Study of a New Investigational Medicinal Product to Treat Patients With Advanced or Metastatic Solid Tumors (Ulysse)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03316638
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

Tracking Information
First Submitted Date  ICMJE September 28, 2017
First Posted Date  ICMJE October 20, 2017
Last Update Posted Date April 15, 2020
Actual Study Start Date  ICMJE November 24, 2017
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2020)
  • Incidence of Specific Adverse Events [ Time Frame: 28 days ]
    Identification of Dose-limiting toxicities
  • Incidence of Specific Adverse Events [ Time Frame: From first administration up to 63 days ]
    Identification of Dose-limiting toxicities
Original Primary Outcome Measures  ICMJE
 (submitted: October 17, 2017)
  • Incidence of Specific Adverse Events [ Time Frame: 28 days ]
  • Incidence of Specific Adverse Events [ Time Frame: From first administration up to 63 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of a New Investigational Medicinal Product to Treat Patients With Advanced or Metastatic Solid Tumors
Official Title  ICMJE Phase I/II Open Label Dose Escalation and Dose Expansion Study of Intravenous Infusion of W0101, an Antibody-drug Conjugate, in Patients With Advanced or Metastatic Solid Tumors. International, Multicenter, Open Label Study
Brief Summary

W0101 combines a cytotoxic compound to a monoclonal antibody targeting a receptor commonly overexpressed in many cancers.

The development of antibody-drug conjugates takes advantage of the specificity of the mAb while augmenting its ability to produce a cytotoxic effect. The expected benefits of antibody-drug conjugation are enhancement of cytotoxicity in target cells and limiting toxicities of cytotoxic drugs in normal tissues.

Detailed Description This is a First In Human study, multicenter, open label study divided into 2 parts: an initial dose escalation phase (I) followed by expansion cohort(s) phase (II).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
2 Cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced or Metastatic Solid Tumors
Intervention  ICMJE
  • Drug: W0101 - Cohort A1
    Administered once every 2 weeks
    Other Name: Dose escalation Phase
  • Drug: W0101 - Cohort A2
    Administered every 3 weeks
    Other Name: Dose escalation Phase
  • Drug: W0101 - Expansion Phase
    Administered according to the recommended dose for expansion
    Other Name: Expansion Phase
Study Arms  ICMJE
  • Experimental: W0101 - Cohort A1
    This is a 14 days treatment cycle cohort in a 2 weeks schedule
    Intervention: Drug: W0101 - Cohort A1
  • Experimental: W0101 - Cohort A2
    This is a 21 days treatment cycle cohort in a 3 weeks schedule
    Intervention: Drug: W0101 - Cohort A2
  • Experimental: W0101 - Expansion Phase
    Will be initiated after completion of cohorts A1 and A2
    Intervention: Drug: W0101 - Expansion Phase
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2017)
316
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Dose escalation phase (cohort A1 and A2)

  1. Male or female subjects age ≥ 18 years
  2. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors (excluding lymphoma) , unresponsive to standard treatment or for whom no standard treatment is available or appropriate
  3. ECOG performance status 0 or 1
  4. Adequate bone marrow, renal, hepatic at screening and at Baseline
  5. Subject must have measurable diseases as per RECIST v1.1 criteria

Exclusion Criteria:

  1. Symptomatic brain metastases, CNS tumors
  2. Symptomatic motor or sensory peripheral neuropathy (≥ grade 2)
  3. Subjects having ophthalmologic abnormalities
  4. Active serious systemic disease (infection,organic or dysmetabolic desease)
  5. Left ventricular ejection fraction (LVEF) < 45% as determined by MUGA scan or echography at screening
  6. QTc > 470 msec on screening ECG or congenital long QT syndrome
  7. Biologic therapy (including ADCs ≤ 4 weeks before first study treatment administration)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pierre Fabre Medicament 0033534506000 contact_essais_cliniques@pierre-fabre.com
Listed Location Countries  ICMJE France,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03316638
Other Study ID Numbers  ICMJE W00101IV101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pierre Fabre Medicament
Study Sponsor  ICMJE Pierre Fabre Medicament
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Karim Keddad Pierre Fabre Medicament
PRS Account Pierre Fabre Medicament
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP