A First-In-Human (FIH) Phase I/II Open-label, Multicentre, Dose Escalation and Expansion Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors Including Non-small Cell Lung Cancer (NSCLC) Harboring Mesenchymal-Epithelial Transition (MET) Alterations
Pierre Fabre Medicament
Summary
The goal of this clinical trial is to investigate the safety, the activity of VERT-002 (PFL-002), and the optimal safe dose to be used, in participants with solid tumors including non-small cell lung cancer.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Part 1: histological confirmation of relapsed and/or refractory locally advanced or metastatic solid tumor for which no standard of care treatment is available. 2. Part 2: histological confirmation of locally advanced or metastatic NSCLC Stage IIIB/C or IV (American Joint Commission on Cancer \[AJCC\] 8th edition) in participants who are not eligible for or should have received available standard of care therapies including curative intent surgery, chemoradiation, radiotherapy or systemic therapy. 3. Part 1: presence of at least one of the following MET alterations base…
Interventions
- DrugVERT-002
Route of Administration: Intravenous
Locations (19)
- Georgetown Lombardi Comprehensive Cancer CenterWashington D.C., District of Columbia
- Gabrail Cancer Research CenterCanton, Ohio
- Sarah Cannon Research Institute Oncology PartnersNashville, Tennessee
- Institut Jules BordetAnderlecht
- APHP de Marseille - Hôpital NordMarseille
- Institut de Cancerologie de Ouest (ICO) - Saint-HerblainSaint-Herblain