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

NCT03316638 | Terminated Phase 1 DMC

• 1 other identifier: W00101IV101
• Study Type: interventional
• Target: 316
• Locations: 2 countries
• Sites: 3

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.

Conditions

Advanced or Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

W0101 - Cohort A1

EXPERIMENTAL

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

Drug: W0101 - Cohort A1

W0101 - Cohort A2

EXPERIMENTAL

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

Drug: W0101 - Cohort A2

W0101 - Expansion Phase

EXPERIMENTAL

Will be initiated after completion of cohorts A1 and A2

Drug: W0101 - Expansion Phase

Interventions

W0101 - Cohort A1 DRUG

Administered once every 2 weeks

Also known as: Dose escalation Phase

W0101 - Cohort A1

W0101 - Cohort A2 DRUG

Administered every 3 weeks

Also known as: Dose escalation Phase

W0101 - Cohort A2

W0101 - Expansion Phase DRUG

Administered according to the recommended dose for expansion

Also known as: Expansion Phase

W0101 - Expansion Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Dose escalation phase (cohort A1 and A2)
• Male or female subjects age ≥ 18 years
• 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
• ECOG performance status 0 or 1
• Adequate bone marrow, renal, hepatic at screening and at Baseline
• Subject must have measurable diseases as per RECIST v1.1 criteria

You may not qualify if:

• Symptomatic brain metastases, CNS tumors
• Symptomatic motor or sensory peripheral neuropathy (≥ grade 2)
• Subjects having ophthalmologic abnormalities
• Active serious systemic disease (infection,organic or dysmetabolic desease)
• Left ventricular ejection fraction (LVEF) \< 45% as determined by MUGA scan or echography at screening
• QTc \> 470 msec on screening ECG or congenital long QT syndrome
• Biologic therapy (including ADCs ≤ 4 weeks before first study treatment administration)

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (3)

IUCT

Toulouse, 31059, France

Location

IGR

Villejuif, 94805, France

Location

VHIO

Barcelona, 08035, Spain

Location

Study Officials

• Eric Chetaille, MD

  Pierre Fabre Medicament

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 Cohorts

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 20, 2017
• Study Start: November 24, 2017
• Primary Completion: October 30, 2021
• Study Completion: July 5, 2022
• Last Updated: December 10, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); FR (2)