ABN401 for Advanced Solid Tumors with c-MET Dysregulation
This study is testing vabametkib, a tablet taken by mouth, alone or in combination with lazertinib, also a tablet taken by mouth, for people with advanced solid tumors that have a specific change called c-MET dysregulation. You might be able to join if you have advanced non-small cell lung cancer (NSCLC) or other advanced solid tumors, are at least 18 years old, and have a good general health status. Researchers want to see how well vabametkib works (objective response rate) and if it's safe (side effects). The study aims to enroll about 178 participants.
- Study design
- This is an interventional study with an unclear phase and status, planning to enroll 178 participants across different groups (cohorts).
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints are measured for up to 12 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.
NCT05541822
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation
Recruiting
PHASE2Ages 18+InterventionalTreatmentAbion Inc
~178 participants
Updated 2025-05-22 on ClinicalTrials.gov
What's tested:VabametkibLazertinib
At a glance
Recruiting sites
23 of 24 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cohort 1: Objective response rate (ORR) according to response evaluation criteria in solid tumors (RECIST)1.1 by Blinded Independent Central Review (BICR)
Measured over Up to 12 months
+3 more outcomes measured
Conditions
Where it's being run
24 sites across 7 statesSouth Korea9
Taiwan6
Seoul3
Florida2
Gyeonggi-do2
Michigan1
Texas1
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
Non-squamous histology (confirmed by histology or cytology)
EGFR mutation-positive including exon 19 deletions or exon 21 L858R as detected by an FDA-approved or other validated test in a CLIA certified laboratory (sites in the US) or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. (Note: A copy of the test report documenting the EGFR mutation must be included in the participant records and it must be reviewed by the Medical monitor.)
Radiological documentation of disease progression while on continuous treatment with the 1st line 3rd generation EGFR-TKI
Prior objective clinical benefit defined by either partial or complete radiological response, or durable SD (SD should last \> 6 months) from the 1st line 3rd generation EGFR-TKI
Interval between documentation of radiological progression of disease on the 1st line 3rd generation EGFR TKI and first dose of study drug should be ≤ 60 days
MET amplification or overexpression from tumor sample collected following progression on 1st line 3rd generation EGFR-TKI • Amplification GCN ≥ 10 indicated by FISH (confirmed centrally, slides or image from local laboratory will be confirmed by the central pathologist) or NGS (confirmed either centrally or locally) • Overexpression indicated by IHC90+ (i.e. 3+ staining in ≥ 90% tumor cells by central test, if local IHC results are available, image from local laboratory will be confirmed by central pathologist. Despite the image submission, tissue unstained slides should be sent to central laboratory for confirmation of MET amplification or overexpression.) 5. Treatment experience
collected after progression from most recent prior systemic anti-cancer treatment, OR
If an archival tissue collected after progression to the most recent systemic anti-cancer treatment is not available, tissue samples from previous lines of treatment are acceptable.
Exclusion
Strong and moderate CYP3A4 inducers
Medications possibly prolong QT interval or induce Torsades de Pointes 15. Has received or will receive a live vaccine within 30 days prior to the first administration of study medication. Seasonal flu vaccine that does not contain live vaccine are permitted. 16. Received an investigational product (except for EGFR TKI in Cohort 2) or treated with an investigational device within 30 days prior to first study drug administration. 17. Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors (except for EGFR TKI in Cohort 2) within 2 weeks (4 weeks in case of thoracic radiotherapy to lung fields) or 5 half-lives (whichever is longer) of the start of study treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of study treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of study treatment; 7-day washout is permitted for palliative radiation (i.e. limited field, ≤ 14-day course of radiotherapy) to non-CNS lesions. 18. History or clinical evidence of any surgical or medical condition which the investigator judges as likely to interfere with the results of the study or pose an additional risk in participating e.g., rapidly progressive or uncontrolled disease involving a major organ system-vascular, ophthalmologic, cardiac (clinically important abnormalities in rhythm, conduction or morphology of resting ECG, uncontrolled hypertension, uncontrolled symptomatic heart failure), pulmonary, gastrointestinal, gynecologic, hematologic, neurologic, neoplastic, renal, endocrine, autoimmune or an immunodeficiency, or clinically significant active psychiatric or abuse disorders. 19. Is a regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of substance abuse (including alcohol). 20. Patients with a corrected QT interval (using Fridericia's correction formula) (QTcF) of \> 470 msec. 21. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medications known to prolong QT interval or induce Torsades de Pointes. 22. Congestive heart failure (CHF), defined as New York Heart Association (NYHA) class III-IV or hospitalization for CHF (any NYHA class), within 6 months of randomization. 23. An active or past medical history of pericarditis, pericardial effusion that is clinically unstable, or myocarditis. Pericardial effusion considered due to the disease under study is permitted if clinically stable at Screening. 24. (for Cohort 2) Baseline LVEF either \<50% or below the lower limit of normal (LLN) per institutional guidelines, as assessed by screening echocardiogram or MUGA scan. 25. (for Cohort 2) Patients who have been receiving medications with potential for QT interval prolongation will be eligible only when the wash out period was finished.
What this trial measures
- Cohort 1: Objective response rate (ORR) according to response evaluation criteria in solid tumors (RECIST)1.1 by Blinded Independent Central Review (BICR)Up to 12 months
ORR is defined as the proportion of patients who experience a complete response (CR) or partial response (PR) as measured by RECIST 1.1
- Cohort 2 Part 1: Incidence of DLT (Dose Limiting Toxicity)Up to 12 months
- Cohort 2 Part 2: Optimal dose of vabametkib and lazertinib combination for Part 3 based on the risk-benefit assessment considering both ORR (Objective Response Rate) and AE (Adverse Events)Up to 12 months
- Cohort 2 Part 3: ORR (Objective Response Rate)Up to 12 months