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

Recruiting now · Phase 2

Conditions studied: Advanced Solid Tumors

In brief

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 facts

Study ID

NCT05541822

Run by

Abion Inc

People needed

178

Starts

2023-01-17

Expected to finish

2029-02-01

Last updated by the study team

2025-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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
• i. 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.
• e. 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.

You may not qualify if…

• Previous severe hypersensitivity reaction to any component of study drug(s).
• Prior therapy
• a. Previous treatment with c-MET inhibitors or hepatocyte growth factor (HGF)-targeting therapy.
• b. 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.).
• 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.

Where it is running

• Taipei Veterans General Hospital — Taipei, Taiwan (enrolling)
• Mid Florida Center — Orange City, Florida, United States (enrolling)
• Cancer Care of North Florida, PA (Lake City Cancer Care, LLC) - Medical Oncology — Lake City, Florida, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• National Cancer Center — Goyang-si, Gyeonggi-do, South Korea (enrolling)
• Ajou University Hospital — Suwon, Gyeonggi-do, South Korea (enrolling)
• Boramae Medical Center — Dongjak, Seoul, South Korea (enrolling)
• Korea University Anam Hospital — Seoul, Seoul, South Korea (enrolling)
• Severance Hospital — Sinchon-dong, Seoul, South Korea (enrolling)
• Chungbuk National University Hospital — Cheongju-si, South Korea (enrolling)
• Gachon University Gil Medical Center — Incheon, South Korea (enrolling)
• Gyeongsang National University Hospital — Jinju, South Korea (enrolling)
• Seoul National University Bundang Hospital — Seongnam-si, South Korea (enrolling)
• Kangbuk Samsung Hospital — Seoul, South Korea (enrolling)
• Asan Medical Center — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• The Catholic University of Korea, Seoul St Mary's Hospitals — Seoul, South Korea (enrolling)
• The Catholic University of Korea St Vincents Hospital — Suwon, South Korea (enrolling)
• China Medical University Hospital — Taichung, Taiwan (enrolling)
• National Cheng Kung University Hospital — Tainan, Taiwan (enrolling)
• Chi Mei Hospital, Liouying — Tainan, Taiwan (enrolling)
• National Taiwan University Cancer Center (NTUCC) — Taipei, Taiwan (enrolling)
• National Taiwan University Hospital — Taipei, Taiwan (enrolling)
• The Henry Ford Cancer Institute — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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