Status:
TERMINATED
A Study of a New Investigational Medicinal Product to Treat Patients with Advanced or Metastatic Solid Tumors
Lead Sponsor:
Pierre Fabre Medicament
Conditions:
Advanced or Metastatic Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 specificit...
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).
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 24 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 5 2022
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT03316638
Start Date
November 24 2017
End Date
July 5 2022
Last Update
December 10 2024
Active Locations (3)
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1
IUCT
Toulouse, France, 31059
2
IGR
Villejuif, France, 94805
3
VHIO
Barcelona, Spain, 08035