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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03316638
Recruitment Status : Active, not recruiting
First Posted : October 20, 2017
Last Update Posted : December 20, 2022
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

Study Description
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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.


Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Drug: W0101 - Cohort A1 Drug: W0101 - Cohort A2 Drug: W0101 - Expansion Phase Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 2 Cohorts
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 24, 2017
Actual Primary Completion Date : October 30, 2021
Estimated Study Completion Date : December 30, 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: W0101 - Cohort A1
This is a 14 days treatment cycle cohort in a 2 weeks schedule
 Drug: W0101 - Cohort A1
Administered once every 2 weeks
Other Name: Dose escalation Phase
Experimental: W0101 - Cohort A2
This is a 21 days treatment cycle cohort in a 3 weeks schedule
 Drug: W0101 - Cohort A2
Administered every 3 weeks
Other Name: Dose escalation Phase
Experimental: W0101 - Expansion Phase
Will be initiated after completion of cohorts A1 and A2
 Drug: W0101 - Expansion Phase
Administered according to the recommended dose for expansion
Other Name: Expansion Phase


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Specific Adverse Events [ Time Frame: 28 days ]
    Identification of Dose-limiting toxicities

  2. Incidence of Specific Adverse Events [ Time Frame: From first administration up to 63 days ]
    Identification of Dose-limiting toxicities


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03316638


Locations
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France
IUCT
Toulouse, France, 31059
IGR
Villejuif, France, 94805
Spain
VHIO
Barcelona, Spain, 08035
Sponsors and Collaborators
Pierre Fabre Medicament
Investigators
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Study Chair: Eric Chetaille, MD Pierre Fabre Medicament
More Information
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Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT03316638    
Other Study ID Numbers: W00101IV101
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: December 20, 2022
Last Verified: December 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms