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

Study Overview
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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).

Official Title
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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

Conditions
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Advanced or Metastatic Solid Tumors

Intervention / Treatment
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* Drug: W0101 - Cohort A1
* Drug: W0101 - Cohort A2
* Drug: W0101 - Expansion Phase


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: 2 Cohorts
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: W0101 - Cohort A1<br>This is a 14 days treatment cycle cohort in a 2 weeks schedule | Drug: W0101 - Cohort A1<br>* Administered once every 2 weeks<br>* Other names: Dose escalation Phase;|
| Experimental: W0101 - Cohort A2<br>This is a 21 days treatment cycle cohort in a 3 weeks schedule | Drug: W0101 - Cohort A2<br>* Administered every 3 weeks<br>* Other names: Dose escalation Phase;|
| Experimental: W0101 - Expansion Phase<br>Will be initiated after completion of cohorts A1 and A2 | Drug: W0101 - Expansion Phase<br>* Administered according to the recommended dose for expansion<br>* Other names: Expansion Phase;|

What is the study measuring?
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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 |