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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced or Metastatic Solid Tumors
• Intervention / Treatment: Drug: W0101 - Cohort A1; Drug: W0101 - Cohort A2; Drug: W0101 - Expansion Phase

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: Interventional
• Enrollment (Anticipated): 316
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • IUCT
  • Villejuif, France, 94805
    • IGR
• Spain
  • Barcelona, Spain, 08035
    • VHIO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: Expansion Phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Specific Adverse Events	Identification of Dose-limiting toxicities	28 days
Incidence of Specific Adverse Events	Identification of Dose-limiting toxicities	From first administration up to 63 days

Collaborators and Investigators

• Sponsor: Pierre Fabre Medicament
• Investigators: Study Chair: Eric Chetaille, MD, Pierre Fabre Medicament

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2017
• Primary Completion (Actual): October 30, 2021
• Study Completion (Anticipated): December 30, 2024

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 20, 2017

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: W00101IV101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No