FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations
NCT ID: NCT06669117
Last Updated: 2025-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
140 participants
INTERVENTIONAL
2024-10-22
2032-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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VERT-002 (PFL-002)
Part 1: Dose escalation (Phase Ia): VERT-002 will be administered via intravenous (IV) infusion every 2 weeks. 4 provisional doses are planned. An alternative regimen may be tested informed by the emerging data
Part 2a: Preliminary Activity Assessment (Phase Ib): One dose \& schedule selected from Part 1
Part 2b: Dose range optimization (Phase Ib): 2 or 3 doses \& schedule selected from Part 1: From the lower limit \[Optimal Biologically Active Dose (OBD)\] \& upper limit \[Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) if MTD is not reached\]
Part 3: Dose Expansion at RP2D (Phase II): To be defined later on
VERT-002
Route of Administration: Intravenous
Interventions
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VERT-002
Route of Administration: Intravenous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 based on local documentation of blood or archived tissue results:
* METex14 mutation
* MET kinase domain activating gene mutations (e.g. H1094L/R/Y, D1228H/N/V, Y1230A/C/D/H)
* MET amplification
4. Part 2-a: presence of METex14 mutation (based on local documentation of blood or archived tissue results) and for Part 2-b presence of at least one of the following MET alterations: METex14 mutation (based on local documentation of blood or archived tissue results), de novo MET amplification (based on local documentation of archived tissue results). Confirmation after enrollment in the trial will be performed by central testing from an archival tumor biopsy sample (either tissue block or at least 15 serial cut unstained slides of 5 μm, at least 20% tumor content). In case no archival biopsy is available for central testing, the patient must be willing to have a fresh tumor biopsy sample collected and the tumor biopsy should be deemed safe and feasible by the investigator.
5. Part 2: at least one measurable target lesion according to RECIST v1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
7. Part 1: participants may have received MET Tyrosine Kinase Inhibitor (TKI) as part of previous treatment, regardless of the line of therapy (first or second line), and regardless of the MET TKI being combined or not. Note: crizotinib will be considered a MET TKI.
8. Part 2: a maximum of 3 prior lines of systemic therapies.
9. Adequate hematologic function.
10. Adequate hepatic function.
11. Adequate renal function.
12. Albumin ≥ 3 g/dL.
13. Adequate coagulation function.
14. Adequate cardiac function.
15. Female participants of childbearing potential must have a negative highly sensitive serum β-HCG test performed within 7 days prior to the first dose of VERT-002 and a negative urine pregnancy test performed at C1D1 prior to the first dose of VERT-002.
16. Male participants/partners with female spouse/partners of childbearing potential must agree to take appropriate precautions to avoid fathering a child.
Exclusion Criteria
2. History of a primary malignancy other than the cancer under trial (as defined for Parts 1 and 2) with the exception of:
* Participants with a previous malignancy who completed their anticancer treatment at least 2 years before signing informed consent and with no evidence of residual disease from the prior malignancy at screening.
* Malignancies with a negligible risk of metastasis or death (i.e. 5-year overall survival rate \> 90%) that are adequately treated.
3. Uncontrolled Central Nervous System (CNS) metastases or spinal cord compression that are associated with progressive neurological symptoms or require increasing doses of corticosteroids to control the CNS disease.
4. History of hypersensitivity to active or inactive ingredients of VERT-002, or drugs with a similar chemical structure or from a similar class.
5. Active, bacterial, fungal, or viral infection, within 2 weeks prior to the first dose of VERT-002 (C1D1).
6. Positive SARs-CoV-2 or variants of SARs-CoV2 test within 2 weeks prior to first dose administration of VERT-002 (C1D1) or with suspected infection with SARs-CoV-2 or variants of SARs-CoV-2 and confirmation pending.
7. Impaired cardiovascular function or clinically significant cardiovascular disease (either active or within 6 months prior to signing main informed consent).
8. Uncontrolled intercurrent illness including, but not limited to psychiatric illness or social situation that would limit compliance with trial requirements.
9. Past medical history of Interstitial Lung Disease (ILD), drug induced ILD, radiation pneumonitis that requires steroid treatment, or any evidence of clinically active ILD.
10. Women who are pregnant or breastfeeding.
11. Prior anticancer therapy:
* MET TKI within 7 days prior to the first dose of VERT-002,
* Any other systemic anticancer therapy within 28 days or 5 half-lives of the anticancer therapy whichever is the shortest, but with a minimum of 14 days interval, prior to the first dose of VERT-002 (C1D1),
* Radiotherapy to a large field or including a vital organ (including whole brain radiotherapy or stereotactic radiosurgery to brain) within 14 days prior to the first dose of VERT-002 (C1D1).
12. Live attenuated vaccine within 28 days prior to the first dose of VERT-002 (C1D1).
13. Any toxicities from prior therapy with NCI- CTCAE Grade \> 1 at the time of the first dose administration of VERT-002 (C1D1). Exceptions include any grade alopecia, fatigue and peripheral neuropathy with a grade ≤ 2.
14. Major surgical procedure within 14 days of the first dose of VERT-002 (C1D1).
15. Participation in a clinical trial with administration of an investigational drug within 5 half- lives plus 14 days of the investigational drug, prior to the first dose of VERT-002 (C1D1).
18 Years
ALL
No
Sponsors
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Pierre Fabre Medicament
INDUSTRY
Responsible Party
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Locations
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Georgetown Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, United States
Gabrail Cancer Research Center
Canton, Ohio, United States
Sarah Cannon Research Institute Oncology Partners
Nashville, Tennessee, United States
Institut Jules Bordet
Anderlecht, , Belgium
APHP de Marseille - Hôpital Nord
Marseille, , France
Institut de Cancerologie de Ouest (ICO) - Saint-Herblain
Saint-Herblain, , France
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, , France
Gustave Roussy
Villejuif, , France
Universitaet zu Koeln - Centrum fuer Integrierte Onkologie (CIO)
Cologne, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Azienda Ospedaliero - Universitaria San Luigi Gonzaga
Orbassano, , Italy
Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis
Amsterdam, , Netherlands
Yonsei University College of Medicine
Seoul, , South Korea
Asan Medical Center (AMC)
Seoul, , South Korea
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Medical University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Related Links
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Pierre Fabre's commitment to transparency of clinical study information Pillar 5.
Other Identifiers
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2024-512760-64-00
Identifier Type: CTIS
Identifier Source: secondary_id
F60089IV101
Identifier Type: -
Identifier Source: org_study_id
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