Actively Recruiting
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation
Led by Abion Inc · Updated on 2025-05-22
178
Participants Needed
24
Research Sites
315 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed advanced, recurrent, or metastatic NSCLC
- For Cohort 1: MET exon 14 skipping detected by local or central testing
- For Cohort 2: Non-squamous histology, EGFR mutation-positive, radiological progression on 1st line 3rd generation EGFR-TKI, prior benefit from EGFR-TKI, MET amplification or overexpression after progression
- Cohort 1: Anti-tumor treatment naive or limited prior treatments (no more than 2 regimens)
- Cohort 2: Progressed on 1st line 3rd generation EGFR-TKI
- At least one measurable lesion per RECIST 1.1
- Not pregnant or breastfeeding and agree to contraception requirements during and after study
- Resolution of prior therapy-related side effects to grade 1 or less
- Adequate organ function per lab tests
- Submit required tissue and blood specimens
- Able and willing to comply with study protocol and restrictions
You will not qualify if you...
- Previous severe allergic reaction to study drugs
- Prior treatment with c-MET inhibitors or HGF-targeting therapy
- For Cohort 2, prior chemotherapy for advanced disease
- Known genetic alterations that exclude benefit from study drugs
- Significant liver or biliary tract diseases
- History or signs of interstitial lung disease or pneumonitis requiring steroids
- Gastrointestinal diseases affecting drug absorption
- Prior organ or stem cell transplant
- Active infections with HIV, HTLV-1, HBV, or HCV unless controlled as specified
- Symptomatic ascites or pleural effusion unless stable for 2 weeks
- Active CNS tumors or unstable brain metastases
- Other recent malignancies requiring treatment
- Active infections needing therapy (minor infections may be allowed)
- Recent use of systemic corticosteroids or immunosuppressive drugs
- Use of certain medications affecting drug metabolism or heart rhythm
- Live vaccine within 30 days prior to study
- Recent investigational treatments or therapies
- Medical conditions posing additional risks or interfering with study results
- Substance abuse history within the last year
- Heart conditions including prolonged QT interval, heart failure, or unstable pericardial disease
- For Cohort 2, reduced heart function as measured by LVEF
- For Cohort 2, medications prolonging QT interval unless washout period completed
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 24 locations
1
Cancer Care of North Florida, PA (Lake City Cancer Care, LLC) - Medical Oncology
Lake City, Florida, United States, 32024-3456
Actively Recruiting
2
Mid Florida Center
Orange City, Florida, United States, 32763-8316
Actively Recruiting
3
The Henry Ford Cancer Institute
Detroit, Michigan, United States, 48202
Not Yet Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030-4000
Actively Recruiting
5
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea, 10408
Actively Recruiting
6
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea, 16499
Actively Recruiting
7
Boramae Medical Center
Dongjak, Seoul, South Korea, 07061
Actively Recruiting
8
Korea University Anam Hospital
Seoul, Seoul, South Korea, 02841
Actively Recruiting
9
Severance Hospital
Sinchon-dong, Seoul, South Korea, 03776
Actively Recruiting
10
Chungbuk National University Hospital
Cheongju-si, South Korea, 28645
Actively Recruiting
11
Gachon University Gil Medical Center
Incheon, South Korea, 21565
Actively Recruiting
12
Gyeongsang National University Hospital
Jinju, South Korea, 52728
Actively Recruiting
13
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
14
Kangbuk Samsung Hospital
Seoul, South Korea, 03181
Actively Recruiting
15
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
16
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
17
The Catholic University of Korea, Seoul St Mary's Hospitals
Seoul, South Korea, 06591
Actively Recruiting
18
The Catholic University of Korea St Vincents Hospital
Suwon, South Korea, 16248
Actively Recruiting
19
China Medical University Hospital
Taichung, Taiwan, 404
Actively Recruiting
20
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Actively Recruiting
21
Chi Mei Hospital, Liouying
Tainan, Taiwan, 736
Actively Recruiting
22
National Taiwan University Cancer Center (NTUCC)
Taipei, Taiwan, 10052
Actively Recruiting
23
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
24
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Actively Recruiting
Research Team
V
Viki Kim
CONTACT
J
Jeesun Kim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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