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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Pierre Fabre Medicament
Study ID
NCT06669117
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • MET Alteration
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VERT-002 — DRUG
    Route of Administration: Intravenous

Study Details

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.

Key Dates

Start date
Oct 22, 2024
Status verified
Jun 2025
Primary completion
Oct 21, 2030
Completion
Oct 1, 2032

Study Design

Enrollment
140 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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

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) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Georgetown Lombardi Comprehensive Cancer CenterWashington D.C.District of Columbia20007
Chul Kim, MD (PRINCIPAL_INVESTIGATOR)
Gabrail Cancer Research CenterCantonOhio44718
Nashat Gabrail, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute Oncology PartnersNashvilleTennessee37203
Meredith Ann McKean, MD, MPH (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
Georgetown Lombardi Comprehensive Cancer Center· Washington D.C., DCGabrail Cancer Research Center· Canton, OHSarah Cannon Research Institute Oncology Partners· Nashville, TN

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