NCT05541822 · Abion Inc
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation
What this study is about
ABN401-003 is a Phase 2 clinical study to assess effectiveness, safety, tolerability and how the drug moves through the body profile of ABN401 (vabametkib) in specific populations of advance solid tumors with c-MET alterations as treatment given alone.
View original scientific description
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.
Interventions
DRUG
Vabametkib
Tablets Route of Administration: Oral
DRUG
Lazertinib
Tablets Route of Administration: Oral
Primary outcome measures
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
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)
Time frame: 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)
Time frame: Up to 12 months
Cohort 2 Part 3: ORR (Objective Response Rate)
Time frame: Up to 12 months
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female ≥ 18 years of age or designated age of majority according to the regulatory authorities, whichever is higher. 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS), 0 or 1. 3. Have a life expectancy of at least 3 months. 4. Diagnosis: 1. must have histologically or cytologically confirmed NSCLC, advanced, recurrent, or metastatic, 2. For Cohort 1: MET exon 14 skipping suspected by local or central biomarker assessment. \[local testing is accepted for eligibility; all patients will have confirmation by central laboratory, but this result is not necessary for eligibility; local molecular pathology result will suffice\]. This testing can be from archival or fresh tissue sample and/or blood specimen; any sample, any test positive subjects are eligible. 3. For Cohort 2:
- Non-squamous histology (confirmed by histology or cytology)
- EGFR mutation-positive including exon 19 deletions or exon 21 L858R as detected by
Where
- Lake City, Florida
- Orange City, Florida
- Detroit, Michigan
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 22, 2025 · Source of record for eligibility and locations