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Solid TumorPhase 1/2NCT06669117

FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations

A Phase 1/2 study testing VERT-002 in people with Solid Tumor and MET Alteration, run by Pierre Fabre Medicament at 19 sites in 9 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor, MET Alteration
What is being tested?
VERT-002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
19 sitesin 9 countries
Study dates
22 Oct 2024to 1 Oct 2032
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Part 1: histological confirmation of relapsed and/or refractory locally advanced or metastatic solid tumor for which no standard of care treatment is available.
  • 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.
  • 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
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  • 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.
  • Part 2: at least one measurable target lesion according to RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
  • 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.
  • Part 2: a maximum of 3 prior lines of systemic therapies.
  • Adequate hematologic function.
  • Adequate hepatic function.
  • Adequate renal function.
  • Albumin ≥ 3 g/dL.
  • Adequate coagulation function.
  • Adequate cardiac function.
  • 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.
  • Male participants/partners with female spouse/partners of childbearing potential must agree to take appropriate precautions to avoid fathering a child.
  • NOTE: Other protocol defined inclusion criteria may apply.

Who cannot join

  • Part 2: Documented evidence by local testing of targetable oncogene driver mutations.
  • 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.
  • 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.
  • History of hypersensitivity to active or inactive ingredients of VERT-002, or drugs with a similar chemical structure or from a similar class.
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  • Active, bacterial, fungal, or viral infection, within 2 weeks prior to the first dose of VERT-002 (C1D1).
  • 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.
  • Impaired cardiovascular function or clinically significant cardiovascular disease (either active or within 6 months prior to signing main informed consent).
  • Uncontrolled intercurrent illness including, but not limited to psychiatric illness or social situation that would limit compliance with trial requirements.
  • Past medical history of Interstitial Lung Disease (ILD), drug induced ILD, radiation pneumonitis that requires steroid treatment, or any evidence of clinically active ILD.
  • Women who are pregnant or breastfeeding.
  • 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).
  • Live attenuated vaccine within 28 days prior to the first dose of VERT-002 (C1D1).
  • 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.
  • Major surgical procedure within 14 days of the first dose of VERT-002 (C1D1).
  • 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).
  • NOTE: Other protocol defined exclusion criteria may apply.

Trial locations and contacts

19 sites in 9 countries. Contact the study team or a site near you to ask about taking part.

Medical Officer contact

+33 684 66 43 48

yuhua.wang@pierre-fabre.com

19 sites in 9 countries

France4 sites, 4 recruiting

  • APHP de Marseille - Hôpital Nord

    Marseille, 13915

    Laurent Greillier

    Recruiting

  • Institut de Cancerologie de Ouest (ICO) - Saint-Herblain

    Saint-Herblain, 44805

    Judith Raimbourg

    Recruiting

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse, 31100

    Julien Mazieres

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Recruiting

Other trials in France

United States3 sites, 3 recruiting

  • Gabrail Cancer Research Center

    Canton, Ohio, 44718

    Nashat Gabrail, MD

    Recruiting

  • Sarah Cannon Research Institute Oncology Partners

    Nashville, Tennessee, 37203

    Meredith Ann McKean, MD, MPH

    Recruiting

  • Georgetown Lombardi Comprehensive Cancer Center

    Washington D.C., District of Columbia, 20007

    Chul Kim, MD

    Recruiting

Other trials in United States

Taiwan3 sites, 3 recruiting

  • National Taiwan University Hospital

    Taipei, 100225

    Chia-Chi Lin, MD, PhD

    Recruiting

  • Taipei Medical University Hospital

    Taipei, 110

    Chao-Hua Chiu, MD

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217

    Recruiting

Other trials in Taiwan

Germany2 sites, 2 recruiting

  • Universitaet zu Koeln - Centrum fuer Integrierte Onkologie (CIO)

    Cologne, 45147

    Recruiting

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 1307

    Martin Wermke

    Recruiting

Other trials in Germany

South Korea2 sites, 2 recruiting

  • Yonsei University College of Medicine

    Seoul, 03722

    Sun Min Lim, MD, PhD

    Recruiting

  • Asan Medical Center (AMC)

    Seoul, 05505

    Dae Ho Lee, MD, PhD

    Recruiting

Other trials in South Korea

Spain2 sites, 2 recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Luis Paz-Ares Rodriguez, MD, PhD

    Recruiting

  • Hospital Universitario La Paz

    Madrid, 28046

    Francisco Javier de Castro Carpe

    Recruiting

Other trials in Spain

Belgium1 site, 1 recruiting

  • Institut Jules Bordet

    Anderlecht, 1070

    Recruiting

Other trials in Belgium

Italy1 site, 1 recruiting

  • Azienda Ospedaliero - Universitaria San Luigi Gonzaga

    Orbassano, 10043

    Silvia Novello

    Recruiting

Other trials in Italy

Netherlands1 site, 1 recruiting

  • Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam, 1066 CX

    Gerrina Ruiter, MD, PhD

    Recruiting

Other trials in Netherlands

About this study

Official title: 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

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.

Being tested
VERT-002
Keywords
Locally advanced or metastatic solid tumors, MET alteration, Non-small cell lung cancer
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VERT-002Drug

    Also called PFL-002

    Route of Administration: Intravenous

Study groups in NCT06669117
Study groupRoleWhat they receive
VERT-002 (PFL-002)ExperimentalPart 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
Receives: Drug: VERT-002

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: All parts: Incidence and severity of treatment emergent adverse events (TEAEs)/serious adverse events (SAEs), according to NCI-CTCAE v5.0 criteria.

    Measured: Screening to Safety Follow-up (30 days post last dose)

  2. Tolerability: All parts: Incidence of TEAEs/SAEs leading to VERT-002 dose reduction, interruption or discontinuation.

    Measured: From screening up to 13 months

  3. Part 1: Maximum Tolerated Dose (MTD): Incidence of Dose-Limiting Toxicities (DLTs)

    Measured: From the start of trial treatment until end of Cycle 1 per dose level

  4. Part 1: Optimal Biologically Active Dose (OBD): Incidence on PK/PD and ORR (Objective Response Rate)

    Measured: From the first VERT-002 intake up to 13 months

  5. Part2a: Preliminary activity assessment: ORR and cORR (Confirmed Objective Response Rate)

    Measured: From the start of trial treatment up to 13 months

  6. Part2b: Recommended Phase 2 Dose (RP2D): Incidence on overall safety, PK, PDs and cORR

    Measured: From the start of trial treatment up to 13 months

Secondary outcomes (11)

  1. Serum PK Parameter: Maximum Plasma Concentration (Cmax)

    Measured: Part 1: Cycle 1 and Cycle 2 - Days 1,2,4,8,15 and 22; Cycle 3 onward Day 1 and EOT (up to 8 months). Part 2: Cycle 1 Days 1,8 and 15; Cycle 2 Days 1 and 15; Cycle 3 onward Day 1; and EOT (up to 12 months). Each cycle is 28 Days

  2. Serum PK Parameter: PK exposure parameter: Area Under The Plasma Concentration-Time Curve From Time Zero To Dosing Interval (AUC0-tau)

    Measured: Part 1: Cycle 1 and Cycle 2 - Days 1,2,4,8,15 and 22; Cycle 3 onward Day 1 and EOT (up to 8 months). Part 2: Cycle 1 Days 1,8 and 15; Cycle 2 Days 1 and 15; Cycle 3 onward Day 1; and EOT (up to 12 months). Each cycle is 28 Days

  3. Serum PK Parameter: Accumulation Ratio (Rac) for Maximum Observed Concentration (Cmax) and Area Under The Concentration-Time Curve (AUC)

    Measured: Part 1: Cycle 1 and Cycle 2 - Days 1,2,4,8,15 and 22; Cycle 3 onward Day 1 and EOT (up to 8 months). Part 2: Cycle 1 Days 1,8 and 15; Cycle 2 Days 1 and 15; Cycle 3 onward Day 1; and EOT (up to 12 months). Each cycle is 28 Days

  4. Serum PK Parameter: Trough Concentration (Ctrough)

    Measured: Part 1: Cycle 1 and Cycle 2 - Days 1,2,4,8,15 and 22; Cycle 3 onward Day 1 and EOT (up to 8 months). Part 2: Cycle 1 Days 1,8 and 15; Cycle 2 Days 1 and 15; Cycle 3 onward Day 1; and EOT (up to 12 months). Each cycle is 28 Days

  5. Serum ADA Parameter: Incidence of VERT-002 anti- drug antibodies (ADA)

    Measured: Parts 1 and 2: Cycle 1 Days 1,8, and 15; Cycle 2 Days 1 and 15; Cycle 3 onward Day 1; and EOT (up to 8 months). Each cycle is 28 Days

  6. All Parts: cORR (Confirmed Objective Response Rate) based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 per Investigator's Reviewer (IR)

    Measured: From the start of the treatment to at least 80% of the participants have been followed up for 24 months

  7. All Parts: DCR (Disease Control Rate) based on RECIST version 1.1 per IR

    Measured: From the start of the treatment to at least 80% of the participants have been followed up for 24 months

  8. All Parts: TTR (Time To Response) according to RECIST version 1.1 per IR

    Measured: From the start of the treatment to at least 80% of the participants have been followed up for 24 months

  9. All Parts: Duration Of Response (DOR) according to RECIST v1.1 per IR

    Measured: From the start of the treatment to at least 80% of the participants have been followed up for 24 months

  10. Part 2: Progression Free Survival (PFS) according to RECIST v1.1 per IR

    Measured: From the start of the treatment to at least 80% of the participants have been followed up for 24 months

  11. Part 2: Overall Survival (OS)

    Measured: From the start of the treatment to at least 80% of the participants have been followed up for 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2024
  2. Study start22 Oct 2024
  3. Primary completion21 Oct 2030 (estimated)
  4. Study completion1 Oct 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06669117
Sponsor's protocol ID
F60089IV101
Other IDs
2024-512760-64-00
Status last verified
Jun 2025
First submitted
24 Oct 2024
Last updated
2 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pierre Fabre is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies as defined in our commitments. These requests are reviewed and approved by an independent review panel on the basis of scientific ground. All data provided if any is anonymized to respect the privacy of trial participants in line with applicable laws and regulations.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VERT-002 in people with Solid Tumor and MET Alteration, run by Pierre Fabre Medicament at 19 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in France, United States, Taiwan, Germany, South Korea and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Medical Officer (+33 684 66 43 48, yuhua.wang@pierre-fabre.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety: All parts: Incidence and severity of treatment emergent adverse events (TEAEs)/serious adverse events (SAEs), according to NCI-CTCAE v5.0 criteria. (time frame: Screening to Safety Follow-up (30 days post last dose)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06669117.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.

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