To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation

Part of paid clinical trials in Lake City, Florida.

Sponsor
Abion Inc
Study ID
NCT05541822
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • Vabametkib — DRUG
    Tablets Route of Administration: Oral
  • Lazertinib — DRUG
    Tablets Route of Administration: Oral

Study Details

ABN401-003 is a Phase 2 clinical study to assess efficacy, safety, tolerability and pharmacokinetic profile of ABN401 (vabametkib) in specific populations of advance solid tumors with c-MET alterations as monotherapy.

Key Dates

Start date
Jan 17, 2023
Status verified
May 2025
Primary completion
Feb 28, 2029
Completion
Feb 28, 2029

Study Design

Enrollment
178 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Vabametkib
    Subjects will receive vabametkib 800 mg, monotherapy, administered orally once daily in 21-day cycles
  • Experimental: Cohort 2: Lazertinib & Vabametkib
    Part 1 (Safety Run-in): Subjects will receive lazertinib 240 mg in combination with one of three assigned dose levels of vabametkib, administered orally once daily in 21-day cycles Part 2 (Random Dose Optimization): A maximum of two vabametkib dose levels will be evaluated in this part. Patients will be randomized in 1:1 ratio to vabametkib dose level 1 (selected from Part 1) plus the determined dose of lazertinib or dose level 2 (selected from Part 1) plus the determined dose of lazertinib Part 3 (Randomized Clinical Trial): Patients will be randomized in 1:1 ratio to optimized vabametkib dose (selected from Part 2) plus lazertinib or Standard of Care (SOC) arm. SOC arm will be decided by the time of Part 3 initiation

Primary Outcome Measure

Cohort 1: Objective response rate (ORR) according to response evaluation criteria in solid tumors (RECIST)1.1 by Blinded Independent Central Review (BICR) [ Time Frame: Up to 12 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Cancer Care of North Florida, PA (Lake City Cancer Care, LLC) - Medical OncologyLake CityFlorida32024-3456
Waseemulla Khan
[email protected]
(386) 755-1655
Lilibeth Macias
[email protected]
(386) 755-1655
Mid Florida CenterOrange CityFlorida32763-8316
Santosh Nair
[email protected]
(386) 538-3169
Kiran Penta
[email protected]
(386) 538-3169
The Henry Ford Cancer InstituteDetroitMichigan48202-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-4000
Le Xiuning
[email protected]
(713) 561-2486
Patti Smithwick
[email protected]
(713) 561-2486

Find similar trials in Lake City, FL

By research site
Cancer Care of North Florida, PA (Lake City Cancer Care, LLC) - Medical Oncology· Lake City, FLMid Florida Center· Orange City, FLThe Henry Ford Cancer Institute· Detroit, MIThe University of Texas MD Anderson Cancer Center· Houston, TX

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