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A Study of a New Investigational Medicinal Product to Treat Patients with Advanced or Metastatic Solid Tumors

NCT ID: NCT03316638

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

316 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-24

Study Completion Date

2022-07-05

Brief Summary

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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

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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).

Conditions

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Advanced or Metastatic Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

2 Cohorts
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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W0101 - Cohort A1

This is a 14 days treatment cycle cohort in a 2 weeks schedule

Group Type EXPERIMENTAL

W0101 - Cohort A1

Intervention Type DRUG

Administered once every 2 weeks

W0101 - Cohort A2

This is a 21 days treatment cycle cohort in a 3 weeks schedule

Group Type EXPERIMENTAL

W0101 - Cohort A2

Intervention Type DRUG

Administered every 3 weeks

W0101 - Expansion Phase

Will be initiated after completion of cohorts A1 and A2

Group Type EXPERIMENTAL

W0101 - Expansion Phase

Intervention Type DRUG

Administered according to the recommended dose for expansion

Interventions

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W0101 - Cohort A1

Administered once every 2 weeks

Intervention Type DRUG

W0101 - Cohort A2

Administered every 3 weeks

Intervention Type DRUG

W0101 - Expansion Phase

Administered according to the recommended dose for expansion

Intervention Type DRUG

Other Intervention Names

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Dose escalation Phase Dose escalation Phase Expansion Phase

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pierre Fabre Medicament

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Chetaille, MD

Role: STUDY_CHAIR

Pierre Fabre Medicament

Locations

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IUCT

Toulouse, , France

Site Status

IGR

Villejuif, , France

Site Status

VHIO

Barcelona, , Spain

Site Status

Countries

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France Spain

Other Identifiers

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W00101IV101

Identifier Type: -

Identifier Source: org_study_id