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New treatment option for Solid Tumor
Official title FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations
ClinicalTrials.gov ID: NCT06669117
What this study is testing
What is VERT-002?
VERT-002 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Also referred to as PFL-002.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Part 1: histological confirmation of relapsed and/or refractory locally advanced or metastatic solid tumor for which no standard of care treatment is...
- Part 2: histological confirmation of locally advanced or metastatic NSCLC Stage IIIB/C or IV (American Joint Commission on Cancer [AJCC] 8th edition)...
- 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)
You likely can't join 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...
- 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...
- History of hypersensitivity to active or inactive ingredients of VERT-002, or drugs with a similar chemical structure or from a similar class.
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- 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 may apply.
- 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),
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Canton, Ohio, United States
- Nashville, Tennessee, United States
- Anderlecht, Belgium
- Marseille, France
- Saint-Herblain, France
- Toulouse, France
- Villejuif, France
- Cologne, Germany
- Dresden, Germany
- Orbassano, Italy
- Amsterdam, Netherlands
- Seoul, South Korea
- Madrid, Spain
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Canton, Ohio, United States; Nashville, Tennessee, United States; Anderlecht, Belgium; Marseille, France; Saint-Herblain, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.