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

NCT06669117 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: F60089IV1012024-512760-64-00
• Study Type: interventional
• Target: 140
• Locations: 9 countries
• Sites: 19

Brief 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.

Conditions

Solid Tumor; MET Alteration

Keywords

Locally advanced or metastatic solid tumors; MET alteration; Non-small cell lung cancer

Outcome Measures

Primary Outcomes (6)

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

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

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

  From screening up to 13 months

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

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

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

  From the first VERT-002 intake up to 13 months

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

  From the start of trial treatment up to 13 months

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

  From the start of trial treatment up to 13 months

Secondary Outcomes (11)

• Serum PK Parameter: Maximum Plasma Concentration (Cmax)

  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

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

  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

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

  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

• Serum PK Parameter: Trough Concentration (Ctrough)

  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

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

  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

Study Arms (1)

VERT-002 (PFL-002)

EXPERIMENTAL

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

Drug: VERT-002

Interventions

VERT-002 DRUG

Route of Administration: Intravenous

Also known as: PFL-002

VERT-002 (PFL-002)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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),

Sponsors & Collaborators

• Pierre Fabre Medicament: lead

Study Sites (19)

Georgetown Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

RECRUITING

Gabrail Cancer Research Center

Canton, Ohio, 44718, United States

RECRUITING

Sarah Cannon Research Institute Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Institut Jules Bordet

Anderlecht, 1070, Belgium

RECRUITING

APHP de Marseille - Hôpital Nord

Marseille, 13915, France

RECRUITING

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

Saint-Herblain, 44805, France

RECRUITING

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, 31100, France

RECRUITING

Gustave Roussy

Villejuif, 94805, France

RECRUITING

Universitaet zu Koeln - Centrum fuer Integrierte Onkologie (CIO)

Cologne, 45147, Germany

RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, 1307, Germany

RECRUITING

Azienda Ospedaliero - Universitaria San Luigi Gonzaga

Orbassano, 10043, Italy

RECRUITING

Nederlands Kanker Instituut - Antoni van Leeuwenhoek Ziekenhuis

Amsterdam, 1066 CX, Netherlands

RECRUITING

Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center (AMC)

Seoul, 05505, South Korea

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Universitario La Paz

Madrid, 28046, Spain

RECRUITING

National Taiwan University Hospital

Taipei, 100225, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, 110, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

Related Links

• 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.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Medical Officer

CONTACT

+33 684 66 43 48; yuhua.wang@pierre-fabre.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 1, 2024
• Study Start: October 22, 2024
• Primary Completion (Estimated): October 21, 2030
• Study Completion (Estimated): October 1, 2032
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: This trial data availability is according to the criteria and process described on our website.

Locations

IT (1); DE (2); NL (1); ES (2); BE (1); FR (4); US (3); TW (3); KR (2)