Advanced Solid TumorsPhase 2NCT05541822
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-MET Dysregulation
A Phase 2 study testing Vabametkib and Lazertinib in people with Advanced Solid Tumors, run by Abion Inc at 24 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Vabametkib and Lazertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 24 sitesin 3 countries
- Study dates
- 17 Jan 2023to Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years of age or designated age of majority according to the regulatory authorities, whichever is higher.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS), 0 or 1.
- Have a life expectancy of at least 3 months.
- Diagnosis:
- must have histologically or cytologically confirmed NSCLC, advanced, recurrent, or metastatic,
- 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.
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- 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 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.)
- Treatment experience
- Cohort 1: Anti-tumor treatment naïve subject upon refusal to receive 1st line standard of care, or not tolerated to 1st line standard of care, or progressed after standard of care with no greater than 2 prior treatment regimens (neoadjuvant, adjuvant, and maintenance therapies do not qualify as separate treatment regimens).
- Cohort 2: Progressed on prior the 1st line 3rd generation EGFR-TKI for the treatment of advanced/metastatic NSCLC
- At least one measurable lesion per response evaluation criteria in solid tumors (RECIST) 1.1
- While on study treatment and for 6 months after the last dose of study treatment, a patient must:
- Not breast feed or be pregnant.
- Not donate gametes (ie, eggs or sperm) or freeze for future use for the purpose of assisted reproduction.
- Wear an external condom when engaging in any activity that allows for passage of ejaculate to another person.
- If of childbearing potential
- Have a negative highly sensitive (eg, beta-human chorionic gonadotropin [β-hCG]) pregnancy test at screening and within 72 hours before the first dose of study treatment, and agree to further pregnancy tests, ii. Practice at least 1 highly effective method of contraception; if oral contraceptives are used, a barrier method of contraception must also be used.
- If a patient's partner is of childbearing potential, the participant must use a condom and partner of the participant must also be practicing a highly effective method of contraception. A vasectomized patient must still use a condom, but the partner is not required to use contraception.
- Resolution of prior-therapy-related AEs (including immune-related AEs but excluding alopecia) to ≤ Grade 1 per CTCAE v 5.0, and no treatment for these AEs for at least 2 weeks prior to the time of enrollment. Alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 AEs not constituting a safety risk based on investigator's judgment are acceptable.
- Adequate organ function as indicated by laboratory values.
- Submit tissue and blood specimens.
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- Cohort 1:
- All patients should submit tumor tissue/block collected from fresh biopsy or have available archival formalin-fixed, paraffin-embedded tumor tissue specimen. The archival tissue must be:
- 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.
- For fresh biopsied sample, core needle biopsy is permitted. Samples from fine-needle aspiration (FNA) is not acceptable unless the result of MET exon 14 skipping from local testing is available.
- All patients must submit blood samples.
- Cohort 2:
- All patients should submit either fresh or archival tumor slides/block collected after progression from 1st line 3rd generation EGFR TKI. The archival tissue can be permitted ONLY IF it is collected after progression from 1st line 3rd generation EGFR TKI.
- All patients should submit blood samples. 11. Able and willing to comply with the protocol and the restrictions and assessments therein.
Who cannot join
- Previous severe hypersensitivity reaction to any component of study drug(s).
- Prior therapy
- Previous treatment with c-MET inhibitors or hepatocyte growth factor (HGF)-targeting therapy.
- For Cohort 2, prior chemotherapy for advanced, recurrent, or metastatic setting.
- Genetic analysis results:
- Cohort 1: Existing genetic data from the patient's tumor tissue showing known molecular alterations which would make them eligible for targeted therapies (e.g., EGFR mutations, ALK rearrangements, KRAS mutation, ROS1 translocation, BRAF mutation, RET alteration, and NTRK fusion, etc.).
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- Cohort 2: Patients with known molecular alterations that can't benefit from study medication (e.g., EGFR mutation known to be associated with the resistance to 3rd generation EGFR TKIs, such as C797X or insertion 20, ALK rearrangements, KRAS mutation, ROS1 translocation, BRAF mutation, RET alteration, and NTRK fusion, etc.).
- Chronic inflammatory liver condition. History or clinical evidence of any significant liver or biliary pathology including cirrhosis, infectious disease, inflammatory conditions, steatosis, or cholangitis (including ascending cholangitis, primary sclerosing cholangitis, obstruction, perforation, fistula of biliary tract, spasm of sphincter of Oddi, biliary cyst or biliary atresia).
- Past medical history of Interstitial Lung Disease (ILD)/pneumonitis, drug-induced or radiation ILD/pneumonitis that required steroid treatment or other immune suppressive agents, or evidence of current symptomatic interstitial lung disease or unexplained pulmonary symptoms indicative of ILD such dyspnea, cough, or fever.
- Impairment of Gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drugs (e.g., ulcerative diseases, uncontrolled nausea, uncontrolled vomiting, uncontrolled diarrhea, or malabsorption syndrome)
- Prior organ or stem cell transplant.
- Known active infection with human immunodeficiency virus (HIV), human T-cell leukemia virus, type (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV), unless the patients fall into below categories (patients fall into one of the a, b, c category are eligible to participate)
- HIV
- ✓ CD4+ cells ≥ 350 cells/µL
- ✓ No history of AIDS
- ✓ No history of opportunistic infection in the past 12 months
- HCV
- ✓ Undetectable viral load (Participants positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for hepatitis C RNA)
- HBV ✓ Concurrent HBV treatment and undetectable viral load (Participants with a past or resolved hepatitis B infection defined as the presence of hepatitis B core antibody [anti-HBc] and absence of hepatitis B surface antigen are eligible)
- Symptomatic ascites or pleural effusion, unless clinically stable for at least two weeks following treatment for these conditions (including therapeutic thoraco- or paracentesis).
- Known active central nervous system (CNS) primary tumor or metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to first dose of study medication(s), have no evidence of new or enlarging brain metastases and are off steroids for at least 15 days prior to first dose of study medication(s).
- Presence or history of a malignant disease other than disease to be treated in current protocol that has been diagnosed and/or required therapy within the past 3 years. Exceptions to this exclusion include the following: completely resected basal cell and squamous cell skin cancers, indolent malignancies that currently do not require treatment, and completely resected carcinoma in situ of any type.
- Active infection requiring therapy. However, subject with minor infections requiring oral antibiotics, (e.g., urinary tract infection, Upper respiratory tract infection, etc.) could be eligible based on investigator's judgement.
- Use of systemic corticosteroids > 10 mg/day prednisone or equivalent within 30 days or other immunosuppressive drugs within 30 days prior to first drug administration.
- Patients receiving treatment with medications that meet one of the following criteria and that cannot be discontinued specified period prior to the start of treatment with study drug and for the duration of the study.
- For Vabametkib (Wash-out: 1 week)
- Strong and moderate inhibitors/inducers of P-glycoprotein
- Strong and moderate inhibitors/inducers of CYP3A4
- Proton pump inhibitors (PPI)
- Potassium-competitive acid blockers For Lazertinib
- Strong and moderate CYP3A4 inducers
- Medications possibly prolong QT interval or induce Torsades de Pointes
- 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.
- 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.
- 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.
- 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.
- 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).
- Patients with a corrected QT interval (using Fridericia's correction formula) (QTcF) of > 470 msec.
- 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.
- 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.
- 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.
- (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.
- (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.
Trial locations and contacts
24 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
24 sites in 3 countries
South Korea14 sites, 14 recruiting
- Recruiting
Chungbuk National University Hospital
Cheongju-si, 28645
Ki Hyeong Lee, 82-43-269-6015, kihlee@chungbuk.ac.kr
Inyoung Jeong, 82-10-5579-7261, jeonginyoung22@gmail.com
- Recruiting
Boramae Medical Center
Dongjak, Seoul, 07061
Jin-Soo Kim, 82-2-870-3875, gistmd@gmail.com
Youahn Seo, 82-2-870-3875, uahn57@naver.com
- Recruiting
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Ji-Youn Han, +82319201154, jymama@ncc.re.kr
Ji Won Yoo, 82-10-5620-5953, jiwonyoo@ncc.re.kr
- Recruiting
Gachon University Gil Medical Center
Incheon, 21565
Young Saing Kim, +82-10-3475-2435, zoomboom@gilhospital.com
Hyerim Choi, +82-10-9930-7579, jasmin993075@naver.com
- Recruiting
Gyeongsang National University Hospital
Jinju, 52728
Gyeong-won Lee, +82-55-750-9454, brightree24@gmail.com
Soon Ha Kim, 82-10-9079-8069, soonha109@naver.com
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, 13620
Yu Jung Kim, +82-31-787-7041, cong1005@gmail.com
Bora Yoon, +82-10-2351-0197, purplegirl33@naver.com
- Recruiting
Korea University Anam Hospital
Seoul, Seoul, 02841
Yoon Ji Choi, 82-2-920-6079, yj_choi@korea.ac.kr
Woo-seon Lim, 82-2-920-6079, happyseony@kumc.or.kr
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
Yun-Gyoo Lee, 82-2-2001-1859, yungyoolee@gmail.com
Nara Shin, 82-10-6788-3022, snr150604@daum.net
- Recruiting
Asan Medical Center
Seoul, 05505
Daeho Lee, +82230103214, leedaeho@amc.seoul.kr
Hajin Lee, 82-10-4692-2292, a01046922292@gmail.com
- Recruiting
Samsung Medical Center
Seoul, 06351
Se-hoon Lee, +82234101132, sehoon.lee@samsung.com
SooJung Lee, +82-10-8906-9965, sj62.lee@samsung.com
- Recruiting
The Catholic University of Korea, Seoul St Mary's Hospitals
Seoul, 06591
Jin-Hyoung Kang, +82225613238, oncologykang@naver.com
Joo Yeon Kim, 82-10-3537-3359, jyn1023@naver.com
- Recruiting
Severance Hospital
Sinchon-dong, Seoul, 03776
Hye Ryun Kim, 82-2-2228-8173, nobelg@yuhs.ac
Bo Hyun An, 82-2-2228-8173, scbha@yuhs.ac
- Recruiting
Ajou University Hospital
Suwon, Gyeonggi-do, 16499
Yong Won Choi, 82-31-219-4267, dreamliebe@hanmail.net
Yerim Jung, 82-10-2465-5345, 114907@aumc.ac.kr
- Recruiting
The Catholic University of Korea St Vincents Hospital
Suwon, 16248
Byoung-Yong Shim, +82-31-249-8455, shimby@catholic.ac.kr
Yunhwa Kim, 82-10- 2953- 5676, xxx1205xxx@naver.com
Taiwan6 sites, 6 recruiting
- Recruiting
China Medical University Hospital
Taichung, 404
Te-Chun Hsia, +886 4-22065866, d1914@mail.cmuh.org.tw
Shu Yin Liao, +886-972-723899, asd911102@yahoo.com.tw
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Chun-Hui Lee, +886 972-401657 ext. 3042, chunhui811012@gmail.com
Pei-Hsuan Lin, +886-6-2353535 ext. 3042, linpei1029@gmail.com
- Recruiting
Chi Mei Hospital, Liouying
Tainan, 736
Shang-Wen Chen, +886 6-6226999 ext. 73232, saintwin.chen@gmail.com
Olivia Chen, +886-6-6226999 ext. 73232, hospital77649@gmail.com
- Recruiting
National Taiwan University Cancer Center (NTUCC)
Taipei, 10052
Yang Chih-Hsin, +886-2-23123456 ext. 67855, chihyang@ntu.edu.tw
Ya-Ying Bai, +886-2-23123456 ext. 67855, yaying0508@ntuh.gov.tw
- Recruiting
National Taiwan University Hospital
Taipei, 100
Chih-Hsin Yang, +886 2-23123456 ext. 67511, chihyang@ntu.edu.tw
Ya-Ying Bai, +886-2-23123456 ext. 67855, yaying0508@ntuh.gov.tw
- Recruiting
Taipei Veterans General Hospital
Taipei, 112
Yuh-Min Chen, +886 2-28757865, ymchen@vghtpe.gov.tw
Yu-Ching Fang, +886-2-28712121 ext. 82872, fangyaixian0928@gmail.com
United States4 sites, 4 recruiting
- Not yet recruiting
The Henry Ford Cancer Institute
Detroit, Michigan, 48202
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4000
Le Xiuning, (713) 561-2486, XLe1@mdanderson.org
Patti Smithwick, (713) 561-2486, pjsmithwick@mdanderson.org
- Recruiting
Cancer Care of North Florida, PA (Lake City Cancer Care, LLC) - Medical Oncology
Lake City, Florida, 32024-3456
Waseemulla Khan, (386) 755-1655, wkhan@cancercareofnorthflorida.com
Lilibeth Macias, (386) 755-1655 ext. 6200, LMacias@cancercareofnorthflorida.com
- Recruiting
Mid Florida Center
Orange City, Florida, 32763-8316
Santosh Nair, (386) 538-3169, drsmnair@aorcorp.com
Kiran Penta, (386) 538-3169, kiran@aorcorp.com
About this study
Official title: A Phase 2 Multicenter, Open-Label, Parallel Cohort Expansion Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-Mesenchymal-epithelial Transition Factor (c-MET) Dysregulation
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.
Read the detailed description
This study will start with one cohort and it will be a parallel cohort expansion study.
- Conditions
- Advanced Solid Tumors
- Being tested
- Vabametkib, Lazertinib
- Keywords
- c-MET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VabametkibDrug
Tablets
Route of Administration: Oral
LazertinibDrug
Tablets
Route of Administration: Oral
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Vabametkib | Experimental | Subjects will receive vabametkib 800 mg, monotherapy, administered orally once daily in 21-day cycles Receives: Drug: Vabametkib |
| Cohort 2: Lazertinib & Vabametkib | Experimental | 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 Receives: Drug: Vabametkib; Drug: Lazertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohort 1: Objective response rate (ORR) according to response evaluation criteria in solid tumors (RECIST)1.1 by Blinded Independent Central Review (BICR)
ORR is defined as the proportion of patients who experience a complete response (CR) or partial response (PR) as measured by RECIST 1.1
Measured: Up to 12 months
Cohort 2 Part 1: Incidence of DLT (Dose Limiting Toxicity)
Measured: 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)
Measured: Up to 12 months
Cohort 2 Part 3: ORR (Objective Response Rate)
Measured: Up to 12 months
Secondary outcomes (43)
Cohorts 1 & 2: Objective response rate (ORR) measured by RECIST 1.1 by BICR
ORR is defined as the proportion of patients who experience a CR or PR as measured by RECIST 1.1 by BICR
Measured: Up to 12 months
Cohorts 1 & 2: Duration of response (DoR) as measured by RECIST 1.1 by BICR
DoR as measured by RECIST 1.1 by ICR and investigator will be used. DoR is defined as the time period from documentation of disease response to disease progression.
Measured: Up to 12 months
Cohorts 1 & 2: Disease advanced control rate (DCR) as measured per RECIST 1.1 by BICR
DCR is defined as the proportion of patients who achieve CR, PR, and stable disease (SD) as measured per RECIST 1.1 by ICR and investigator
Measured: Week 12
Cohorts 1 & 2: Progression-free survival (PFS) according to RECIST 1.1 by BICR
PFS defined as the time from first dose of vabametkib until disease progression according to RECIST 1.1 by investigator
Measured: Up to 18 months
Cohorts 1 & 2: Overall survival (OS) according to RECIST 1.1
OS defined as the time from first dose of study drug until death from any cause
Measured: Up to 18 months
Cohort 1: Incidence of AEs of vabametkib
Safety and tolerability will be a comprehensive evaluation of AEs based on:
- Incidence of AEs (including grade 3 and 4 TEAEs)
- Vital signs measurements
- Clinical laboratory analyses
- ECGs
- Physical examination findings
- Visual examinations
- Concomitant medications monitored throughout the study
Measured: Up to 12 months
Cohort 2: Incidence of AEs of vabametkib with lazertinib combination
Safety and tolerability will be a comprehensive evaluation of AEs based on:
- Incidence of AEs (including grade 3 and 4 TEAEs)
- Vital signs measurements
- Clinical laboratory analyses
- ECGs (electrocardiogram)
- ECHO (Echocardiography) or MUGA (Multiple Gated Acquisition) scans
- Physical examination findings
- Visual examinations
- Concomitant medications monitored throughout the study
Measured: Up to 12 months
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Tmax: Time to reach maximum concentration
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Tmax: Time to reach maximum concentration
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Cmax: Maximum concentration
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Cmax: Maximum concentration
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Ke: apparent first-order terminal elimination rate constant
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Ke: apparent first-order terminal elimination rate constant
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - T1/2: apparent first-order terminal elimination half-life
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - T1/2: apparent first-order terminal elimination half-life
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-t: area under the concentration-time curve from time zero to the last measurable concentration
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-t: area under the concentration-time curve from time zero to the last measurable concentration
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-12: area under the concentration-time curve from time zero to 12 hr post-dose
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-12: area under the concentration-time curve from time zero to 12 hr post-dose
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-24: area under the concentration-time curve from time zero to 24 hr post-dose
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-24: area under the concentration-time curve from time zero to 24 hr post-dose
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-tau: area under the plasma concentration-time curve from time zero to next dosing
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-tau: area under the plasma concentration-time curve from time zero to next dosing
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-∞: area under the plasma concentration-time curve from time zero to infinity
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-∞: area under the plasma concentration-time curve from time zero to infinity
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - %Extrap: percentage of AUC0-∞ obtained by extrapolation
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - %Extrap: percentage of AUC0-∞ obtained by extrapolation
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Cave: average concentration over a dosage interval
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Cave: average concentration over a dosage interval
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - FLUCP: fluctuation over a dosage interval
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - FLUCP: fluctuation over a dosage interval
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - R: accumulation ratio
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - R: accumulation ratio
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - CL/F: apparent systemic clearance
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - CL/F: apparent systemic clearance
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Vss/F: apparent volume of distribution at steady-state
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Vss/F: apparent volume of distribution at steady-state
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Vz/F: apparent volume of distribution
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Vz/F: apparent volume of distribution
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Cmin: minimum concentration during dosage interval
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Cmin: minimum concentration during dosage interval
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Ctrough: concentration of the drug just prior to administration of next dosage
Measured: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Ctrough: concentration of the drug just prior to administration of next dosage
Measured: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start17 Jan 2023
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abion Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541822
- Sponsor's protocol ID
- ABN401-003
- Status last verified
- May 2025
- First submitted
- 4 Sep 2022
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim DK, Park JW, Cho HB, Choi SJ, Lee SS, Kim Y, Lee JB, Lim SM, Yu MR, Cho BC. Synergistic Antitumor Activity of Combination Therapy with a MET TKI Vabametkib and a Third-Generation EGFR TKI Lazertinib in MET-Amplified EGFR-Mutant NSCLC. Cancer Res Treat. 2026 Mar 31. doi: 10.4143/crt.2025.1399. Online ahead of print.
PubMed 41927036
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Open-Label, Parallel Cohort Expansion Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetic Profile of ABN401 in Patients With Advanced Solid Tumors Harboring c-Mesenchymal-epithelial Transition Factor (c-MET) Dysregulation
- ClinicalTrials.gov ID
- NCT05541822
- Acronym / sponsor ID
- ABN401-003
- Conditions
- Advanced Solid Tumors
- Keywords
- c-MET
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Abion IncIndustry (pharma, biotech, devices)
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will start with one cohort and it will be a parallel cohort expansion study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Vabametkib | Experimental | Drug: VabametkibSubjects will receive vabametkib 800 mg, monotherapy, administered orally once daily in 21-day cycles |
| Cohort 2: Lazertinib & Vabametkib | Experimental | Drug: Vabametkib, Drug: LazertinibPart 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- Male or female ≥ 18 years of age or designated age of majority according to the regulatory authorities, whichever is higher.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS), 0 or 1.
- Have a life expectancy of at least 3 months.
- Diagnosis:
- Treatment experience
Key exclusion criteria (43 listed)
- Previous severe hypersensitivity reaction to any component of study drug(s).
- Prior therapy
- Genetic analysis results:
- Chronic inflammatory liver condition. History or clinical evidence of any significant liver or biliary pathology including cirrhosis, infectious disease, inflammatory conditions, steatosis, or cholangitis (including ascending cholangitis, primary sclerosing cholangitis, obstruction, perforation, fistula of biliary tract, spasm of sphincter of Oddi, biliary cyst or biliary atresia).
- Past medical history of Interstitial Lung Disease (ILD)/pneumonitis, drug-induced or radiation ILD/pneumonitis that required steroid treatment or other immune suppressive agents, or evidence of current symptomatic interstitial lung disease or unexplained pulmonary symptoms indicative of ILD such dyspnea, cough, or fever.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VabametkibTablets Route of Administration: Oral | Drug | Cohort 1: Vabametkib, Cohort 2: Lazertinib & Vabametkib |
| LazertinibTablets Route of Administration: Oral | Drug | Cohort 2: Lazertinib & Vabametkib |
Primary outcome
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
43 secondary outcomes
Cohorts 1 & 2: Objective response rate (ORR) measured by RECIST 1.1 by BICR
Time frame: Up to 12 months
Cohorts 1 & 2: Duration of response (DoR) as measured by RECIST 1.1 by BICR
Time frame: Up to 12 months
Cohorts 1 & 2: Disease advanced control rate (DCR) as measured per RECIST 1.1 by BICR
Time frame: Week 12
Cohorts 1 & 2: Progression-free survival (PFS) according to RECIST 1.1 by BICR
Time frame: Up to 18 months
Cohorts 1 & 2: Overall survival (OS) according to RECIST 1.1
Time frame: Up to 18 months
Cohort 1: Incidence of AEs of vabametkib
Time frame: Up to 12 months
Cohort 2: Incidence of AEs of vabametkib with lazertinib combination
Time frame: Up to 12 months
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Tmax: Time to reach maximum concentration
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Tmax: Time to reach maximum concentration
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Cmax: Maximum concentration
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Cmax: Maximum concentration
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Ke: apparent first-order terminal elimination rate constant
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Ke: apparent first-order terminal elimination rate constant
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - T1/2: apparent first-order terminal elimination half-life
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - T1/2: apparent first-order terminal elimination half-life
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-t: area under the concentration-time curve from time zero to the last measurable concentration
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-t: area under the concentration-time curve from time zero to the last measurable concentration
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-12: area under the concentration-time curve from time zero to 12 hr post-dose
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-12: area under the concentration-time curve from time zero to 12 hr post-dose
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-24: area under the concentration-time curve from time zero to 24 hr post-dose
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-24: area under the concentration-time curve from time zero to 24 hr post-dose
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-tau: area under the plasma concentration-time curve from time zero to next dosing
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-tau: area under the plasma concentration-time curve from time zero to next dosing
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-∞: area under the plasma concentration-time curve from time zero to infinity
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - AUC0-∞: area under the plasma concentration-time curve from time zero to infinity
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - %Extrap: percentage of AUC0-∞ obtained by extrapolation
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - %Extrap: percentage of AUC0-∞ obtained by extrapolation
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Cave: average concentration over a dosage interval
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Cave: average concentration over a dosage interval
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - FLUCP: fluctuation over a dosage interval
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - FLUCP: fluctuation over a dosage interval
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - R: accumulation ratio
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - R: accumulation ratio
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - CL/F: apparent systemic clearance
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - CL/F: apparent systemic clearance
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Vss/F: apparent volume of distribution at steady-state
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Vss/F: apparent volume of distribution at steady-state
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Vz/F: apparent volume of distribution
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Sparse Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Vz/F: apparent volume of distribution
Time frame: Cycle 1: Day 1, Even cycles: Day 1 until disease progression (PD) or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Cohorts 1 & 2: Intensive Sampling - Pharmacokinetic (PK) parameter from plasma vabametkib concentration - Cmin: minimum concentration during dosage interval
Time frame: Cycle 1: Days 1, 2, 15, and 16 (pre-dose). Pre-dose on Day 1 from Cycle 2 Day 1 onward until disease progression (PD), or discontinuation of treatment for any other reason. Each cycle is 21 days (Up to approximately 6 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 41927036Kim DK, Park JW, Cho HB, Choi SJ, Lee SS, Kim Y, Lee JB, Lim SM, Yu MR, Cho BC. Synergistic Antitumor Activity of Combination Therapy with a MET TKI Vabametkib and a Third-Generation EGFR TKI Lazertinib in MET-Amplified EGFR-Mutant NSCLC. Cancer Res Treat. 2026 Mar 31. doi: 10.4143/crt.2025.1399. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
24 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vabametkib and Lazertinib in people with Advanced Solid Tumors, run by Abion Inc at 24 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in South Korea, Taiwan, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viki Kim (82-2-6006-4767, viki.kim@abionbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05541822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.