Actively Recruiting
FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations
Led by Pierre Fabre Medicament · Updated on 2025-07-02
140
Participants Needed
19
Research Sites
414 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Part 1: Confirmed relapsed or refractory locally advanced or metastatic solid tumor with no standard treatment available.
- Part 2: Confirmed locally advanced or metastatic NSCLC Stage IIIB/C or IV not eligible for or having received standard therapies.
- Part 1: Presence of METex14 mutation, MET kinase domain activating mutations, or MET amplification.
- Part 2-a: Presence of METex14 mutation; Part 2-b: Presence of METex14 mutation or de novo MET amplification.
- Measurable target lesion according to RECIST v1.1 for Part 2.
- ECOG performance status of 0 or 1.
- Part 1: Previous MET Tyrosine Kinase Inhibitor treatment allowed.
- Part 2: Up to 3 prior systemic therapy lines.
- Adequate hematologic, hepatic, renal, coagulation, and cardiac function.
- Albumin level ≥ 3 g/dL.
- Female participants of childbearing potential must have negative pregnancy tests before dosing.
- Male participants with female partners of childbearing potential must agree to use precautions to avoid fathering a child.
You will not qualify if you...
- Part 2: Presence of targetable oncogene driver mutations.
- History of other primary malignancies unless treated over 2 years ago with no residual disease or with negligible metastasis risk.
- Uncontrolled CNS metastases or spinal cord compression with worsening symptoms or increasing corticosteroid needs.
- Hypersensitivity to VERT-002 or related drugs.
- Active infection or positive SARs-CoV-2 test within 2 weeks before dosing.
- Significant cardiovascular disease or impaired function within 6 months.
- Uncontrolled illness or social situations limiting trial compliance.
- History or evidence of Interstitial Lung Disease or related lung conditions requiring steroid treatment.
- Pregnancy or breastfeeding.
- Recent anticancer therapies including MET TKI within 7 days, systemic therapy within 14 to 28 days, or radiotherapy within 14 days before dosing.
- Live attenuated vaccine within 28 days before dosing.
- Toxicities from prior therapy above grade 1 except certain mild symptoms.
- Major surgery within 14 days before dosing.
- Recent participation in another investigational drug trial within specified washout periods.
AI-Screening
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Trial Site Locations
Total: 19 locations
1
Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
2
Gabrail Cancer Research Center
Canton, Ohio, United States, 44718
Actively Recruiting
3
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
4
Institut Jules Bordet
Anderlecht, Belgium, 1070
Actively Recruiting
5
APHP de Marseille - Hôpital Nord
Marseille, France, 13915
Actively Recruiting
6
Institut de Cancerologie de Ouest (ICO) - Saint-Herblain
Saint-Herblain, France, 44805
Actively Recruiting
7
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France, 31100
Actively Recruiting
8
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
9
Universitaet zu Koeln - Centrum fuer Integrierte Onkologie (CIO)
Cologne, Germany, 45147
Actively Recruiting
10
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany, 1307
Actively Recruiting
11
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, Italy, 10043
Actively Recruiting
12
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, Netherlands, 1066 CX
Actively Recruiting
13
Yonsei University College of Medicine
Seoul, South Korea, 03722
Actively Recruiting
14
Asan Medical Center (AMC)
Seoul, South Korea, 05505
Actively Recruiting
15
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
16
Hospital Universitario La Paz
Madrid, Spain, 28046
Actively Recruiting
17
National Taiwan University Hospital
Taipei, Taiwan, 100225
Actively Recruiting
18
Taipei Medical University Hospital
Taipei, Taiwan, 110
Actively Recruiting
19
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
Research Team
M
Medical Officer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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