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

Phase 1

Terminated

• Conditions: Advanced or Metastatic Solid Tumors
• Interventions: Drug: W0101 - Cohort A1; Drug: W0101 - Cohort A2; Drug: W0101 - Expansion Phase

• Registration Number: NCT03316638
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-20
• Study Start: 2017-11-24
• Primary Completion: 2021-10-30
• Study Completion: 2022-07-05
• Status Verified: 2022-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 316

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
W0101 - Cohort A1	W0101 - Cohort A1	This is a 14 days treatment cycle cohort in a 2 weeks schedule
W0101 - Cohort A2	W0101 - Cohort A2	This is a 21 days treatment cycle cohort in a 3 weeks schedule
W0101 - Expansion Phase	W0101 - Expansion Phase	Will be initiated after completion of cohorts A1 and A2

Primary Outcome Measures

Name	Time	Method
Incidence of Specific Adverse Events	From first administration up to 63 days	Identification of Dose-limiting toxicities

Trial Locations

Locations (3)

IUCT; 🇫🇷 Toulouse, France

IGR; 🇫🇷 Villejuif, France

VHIO; 🇪🇸 Barcelona, Spain