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

Inclusion Criteria:

1. Male or female ≥ 18 years of age or designated age of majority according to theregulatory 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:

5. must have histologically or cytologically confirmed NSCLC, advanced, recurrent,or metastatic,

6. For Cohort 1: MET exon 14 skipping suspected by local or central biomarkerassessment. [local testing is accepted for eligibility; all patients will haveconfirmation by central laboratory, but this result is not necessary foreligibility; local molecular pathology result will suffice]. This testing canbe from archival or fresh tissue sample and/or blood specimen; any sample, anytest positive subjects are eligible.

7. Treatment experience a. Cohort 1: Anti-tumor treatment naïve subject upon refusal to receive 1st linestandard of care, or not tolerated to 1st line standard of care, or progressed afterstandard of care with no greater than 2 prior treatment regimens (neoadjuvant,adjuvant, and maintenance therapies do not qualify as separate treatment regimens).

8. At least one measurable lesion per response evaluation criteria in solid tumors (RECIST) 1.1, with the exception of bone-only disease (i.e., non-measurable diseaseper RECIST 1.1) with at least 1 radiological non-target lesion.

9. If not menopausal or surgically sterile, willing to practice at least one of thefollowing highly effective methods of birth control for at least a (partner's)menstrual cycle before and for 3 months after study drug administration:

10. Barrier type devices (examples are condom, diaphragm, and contraceptive sponge)used only in combination with a spermicide

11. Sexual intercourse with vasectomized male/sterilized female partner,

12. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable, ortransdermal) for at least 3 consecutive months prior to investigational productadministration (when not clinically contraindicated as in breast, ovarian andendometrial cancers),

13. Use of an intrauterine contraceptive device. Note: Abstinence, the rhythmmethod, and/or contraception by the partner are not acceptable methods of birthcontrol

14. Resolution of prior-therapy-related AEs (including immune-related AEs but excludingalopecia) 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, orother Grade ≤ 2 AEs not constituting a safety risk based on investigator's judgmentare acceptable.

15. Adequate organ function as indicated by laboratory values.

16. Tissue and blood specimens

17. Willing to undergo a new 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-cancertreatment, OR
• tissue samples collected prior to previous lines of treatment,

2. ALL subjects must undergo blood sample for biomarker assessment.

3. Able and willing to comply with the protocol and the restrictions and assessmentstherein.

Exclusion Criteria:

1. Previous severe hypersensitivity reaction to any component of study drug(s).

2. Prior therapy a. Previous treatment with c-MET inhibitors or hepatocyte growth factor (HGF)-targeting therapy.

3. Genetic analysis results: a. Cohort 1: Existing genetic data from the patient's tumor tissue showing knownmolecular alterations which would make them eligible for targeted therapies (e.g.,EGFR mutations, ALK rearrangements, KRAS mutation, ROS1 translocation, BRAFmutation, RET alteration, and NTRK fusion, etc.).

4. Chronic inflammatory liver condition. History or clinical evidence of anysignificant 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).

5. Presence or history of interstitial lung disease or interstitial pneumonitis,including clinically significant radiation pneumonitis

6. Impairment of GI function or GI disease that may significantly alter the absorptionof ABN401 (e.g., ulcerative diseases, uncontrolled nausea, uncontrolled vomiting,uncontrolled diarrhea, or malabsorption syndrome)

7. Prior organ or stem cell transplant.

8. Known active infection with human immunodeficiency virus (HIV), human T-cellleukemia 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) a. HIV

• CD4+ cells ≥ 350 cells/µL

• No history of AIDS

• No history of opportunistic infection in the past 12 months b. HCV

• Undetectable viral load (Participants positive for hepatitis C antibody areeligible only if polymerase chain reaction is negative for hepatitis C RNA) c.HBV

• Concurrent HBV treatment and undetectable viral load (Participants with a pastor resolved hepatitis B infection defined as the presence of hepatitis B coreantibody [anti-HBc] and absence of hepatitis B surface antigen are eligible)

9. Symptomatic ascites or pleural effusion, unless clinically stable for at least twoweeks following treatment for these conditions (including therapeutic thoraco- orparacentesis).

10. Known active central nervous system (CNS) primary tumor or metastases and/orcarcinomatous meningitis. Patients with previously treated brain metastases mayparticipate provided they are clinically stable for at least 4 weeks prior to firstdose of ABN401, have no evidence of new or enlarging brain metastases and are offsteroids for at least 15 days prior to first dose of ABN401.

11. Presence or history of a malignant disease other than disease to be treated incurrent protocol that has been diagnosed and/or required therapy within the past 3years. Exceptions to this exclusion include the following: completely resected basalcell and squamous cell skin cancers, indolent malignancies that currently do notrequire treatment, and completely resected carcinoma in situ of any type.

12. Active infection requiring therapy. However, subject with minor infections requiringoral antibiotics, (e.g., urinary tract infection, Upper respiratory tract infection,etc.) could be eligible based on investigator's judgement.

13. Use of systemic corticosteroids > 10 mg/day prednisone or equivalent within 30 daysor other immunosuppressive drugs within 30 days prior to first drug administration.

14. Patients receiving treatment with medications that meet one of the followingcriteria and that cannot be discontinued at least 1 week prior to the start oftreatment with ABN401 and for the duration of the study

• Strong and moderate inhibitors/inducers of P-glycoprotein

• Strong and moderate inhibitors/inducers of CYP3A4

• Proton pump inhibitors (PPI)

15. Has received or will receive a live vaccine within 30 days prior to the firstadministration of study medication. Seasonal flu vaccine that does not contain livevaccine are permitted.

16. Received an investigational product or treated with an investigational device within 30 days prior to first ABN401 administration.

17. Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents ortyrosine kinase inhibitors within 2 weeks (4 weeks in case of thoracic radiotherapyto lung fields) or 5 half-lives (whichever is longer) of the start of studytreatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of studytreatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6weeks of the start of study treatment; 7-day washout is permitted for palliativeradiation (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 theinvestigator judges as likely to interfere with the results of the study or pose anadditional risk in participating e.g., rapidly progressive or uncontrolled diseaseinvolving a major organ system-vascular, cardiac, pulmonary, gastrointestinal,gynecologic, hematologic, neurologic, neoplastic, renal, endocrine, autoimmune or animmunodeficiency, or clinically significant active psychiatric or abuse disorders.

19. Is a regular user (including "recreational use") of any illicit drugs or had arecent history (within the last year) of substance abuse (including alcohol).

20. Pregnant or breastfeeding or expecting to conceive or father children within theprojected duration of the study.

21. Patients with a corrected QT interval (using Fridericia's correction formula) (QTcF)of > 470 msec (females) and > 450 msec (males).