VERT-002 for Solid Tumors with MET Alterations
This study is testing a new drug called VERT-002 in people with locally advanced or metastatic (spread to other parts of the body) solid tumors, including a type of lung cancer called non-small cell lung cancer (NSCLC). To join, your tumor must have specific changes in a gene called MET. Researchers want to find the safest and most effective dose of VERT-002, which works by blocking certain proteins (kinase inhibitor, tyrosine kinase) that can help cancer grow. The main goals are to understand how safe VERT-002 is and what side effects it might cause. The study plans to enroll about 140 participants, but its current status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 140 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored from screening until 30 days after your last dose of VERT-002. Tolerability will be measured for up to 13 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06669117
FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations
Recruiting
PHASE1Ages 18+InterventionalTreatmentPierre Fabre Medicament
~140 participants
Updated 2025-07-02 on ClinicalTrials.gov
What's tested:VERT-002
At a glance
Recruiting sites
19 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety: All parts: Incidence and severity of treatment emergent adverse events (TEAEs)/serious adverse events (SAEs), according to NCI-CTCAE v5.0 criteria.
Measured over Screening to Safety Follow-up (30 days post last dose)
+5 more outcomes measured
Conditions
Where it's being run
19 sites across 11 statesFrance4
Taiwan3
Germany2
South Korea2
Spain2
District of Columbia1
Ohio1
Tennessee1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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).
What this trial measures
- 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 cORRFrom the start of trial treatment up to 13 months