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

Advanced or Metastatic Solid Tumors Clinical Trial

— Ulysse  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03316638
• Other study ID #: W00101IV101
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 24, 2017
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2022
• Source: Pierre Fabre Medicament
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 316
• Est. completion date: December 30, 2024
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• W0101 - Cohort A1
Administered once every 2 weeks
• W0101 - Cohort A2
Administered every 3 weeks
• W0101 - Expansion Phase
Administered according to the recommended dose for expansion

Locations

Country	Name	City	State
France	IUCT	Toulouse
France	IGR	Villejuif
Spain	VHIO	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Medicament

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Specific Adverse Events	Identification of Dose-limiting toxicities	28 days
Primary	Incidence of Specific Adverse Events	Identification of Dose-limiting toxicities	From first administration up to 63 days