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A Research Study of a New Investigational Medicinal Product for the Treatment of Patients With Advanced or Metastatic Solid Tumors

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ClinicalTrials.gov Identifier: NCT03316638
Recruitment Status : Recruiting
First Posted : October 20, 2017
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament

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.

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).


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 316 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
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
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : September 30, 2022

Arm Intervention/treatment
Experimental: W0101 - Cohort A1 Drug: W0101 - Cohort A1
Administered once every 2 weeks (Q2W)
Other Name: Dose escalation Phase

Experimental: W0101 - Cohort A2
Cohort A2 starts after completion of cohort A1
Drug: W0101 - Cohort A2
Administered every 3 or 4 weeks (Q3W or Q4W)
Other Name: Dose escalation Phase

Experimental: W0101 - Expansion Phase Drug: W0101 - Expansion Phase
Administered according to recommended dose for expansion




Primary Outcome Measures :
  1. Incidence of Specific Adverse Events [ Time Frame: 28 days ]
  2. Incidence of Specific Adverse Events [ Time Frame: From first administration up to 63 days ]


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)

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


Contacts
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Contact: Pierre Fabre Medicament 0033534506000 contact_essais_cliniques@pierre-fabre.com

Locations
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France
IUCT Recruiting
Toulouse, France, 31059
IGR Recruiting
Villejuif, France, 94805
Spain
VHIO Recruiting
Barcelona, Spain, 08035
Sponsors and Collaborators
Pierre Fabre Medicament
Investigators
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Study Director: Karim Keddad Pierre Fabre Medicament

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Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT03316638     History of Changes
Other Study ID Numbers: W00101IV101
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No