To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of ABN401 in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer Harboring c-MET Dysregulation

Inclusion Criteria:

1. Signed informed consent before any study-specific screening procedures.

2. Male or female ≥ 18 years of age or designated age of majority according toregulatory authorities, whichever is higher.

3. Body weight ≥ 40 kg and ≤ 110 kg.

4. Eastern Cooperative Oncology Group (ECOG) performance status (PS), 0 or 1.

5. Diagnosis:

6. For the Phase 1 dose escalation, must have:

• Histological or cytological diagnosis of melanoma or any type of carcinomaor sarcoma,
• Refractory metastatic disease, or refractory locally advanced disease notamenable to local therapy,
• Metastatic breast or prostate cancer may have bone-only disease.

2. For the Phase 1 extension (pilot expansion), patients must have NSCLC withc-MET overexpression, MET amplification, or MET exon 14 skipping by localbiomarker assessment as defined in study protocol. The number of patients withonly c-MET overexpression is limited to 50% of enrolled patients in that dosingcohort including escalation and extension.

3. Progressive disease: a. Phase 1: Progressive disease on established standard medical anti-cancer therapyfor his/her tumor type or intolerant to such therapy, or in the opinion of theinvestigator considered ineligible for a particular form of standard therapy onmedical grounds.

4. 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.

5. 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:

6. True abstinence, when this is in line with the preferred and usual lifestyle ofthe patient, from sexual intercourse with a member of the opposite sex,

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

8. 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),

9. Use of an intrauterine contraceptive device.

10. Resolution of prior-therapy-related AEs (including immune-related AEs but excludingalopecia) to ≤ Grade 1 per CTCAE, and no treatment for these AEs for at least 2weeks 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.

11. Phase 1 only: minimum of 2 weeks since last dose of hormone therapy.

12. Minimum of > 2 weeks or > 5 half-lives (whichever is longer) between the start ofstudy treatment since last dose of radiotherapy, chemotherapy, or molecularlytargeted agents or tyrosine kinase inhibitors; minimum of > 3 weeks of the start ofstudy treatment since last dose of immunotherapy/monoclonal antibodies; > 6 weeks ofthe start of study treatment since the last dose of nitrosoureas, antibody-drugconjugates or radioactive isotopes.

13. Adequate organ function as indicated by the laboratory values.

14. Tissue and/or blood specimens: a. Phase 1: Available archival formalin-fixed, paraffin-embedded tumor tissuespecimen. The archival tissue must be:

• collected after progression from most recent prior systemic anti-cancertreatment, OR

• the samples of previous lines of treatment. If patient wants to participate tothe study but does not want to give the blood and tissue samples for theexploratory study, patient might be able to participate after discussion andapproval of sponsor and the medical monitor.

14. If the patient agrees to optional pre- and/or study new tumor biopsies (that can bebiopsied based on investigator's assessment) and to provide the tissue for biomarkeranalysis, a signed informed consent for the biopsy is required. Tissue obtained forthe biopsy must not be previously irradiated. No systemic antineoplastic therapy maybe received by the patient between the time of the biopsy and the firstadministration of ABN401. For escalation, each dose escalation cohort must try to enroll at least 1 patientwho agrees to biopsies. An exception to the requirement for a new tumor biopsy in atleast one patient per dose level is that if the first patient in a single dosecohort does not consent to a new tumor biopsy and the cohort is not expanded to 3 or 6 patients, a biopsy will not be required in that cohort. Note: During pre-treatmentFFPE tissue samples (unstained slides or blocks) or new frozen tissue may beprovided for tumor analyses.

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

Exclusion Criteria:

1. Previous severe hypersensitivity reaction to any component of ABN401.

2. Prior therapy: a. Phase 1: Treatment with more than 4 lines of prior systemic therapy forrecurrent/metastatic disease. If the patient was treated with more than 4 lines buthis/her condition is eligible to participate to the trial by the investigator'sjudgement, the patient might be able to be enrolled to the trial under the medicalmonitor and the sponsor's approval,

3. Genetic analysis: a. Phase 1 Extension Cohort, existing data by genetic analysis of the patient'stumor tissue that may result in an increased probability of being resistant to c-METinhibitors, including 1) EGFRi; 2) ALKi; 3) ROSi; 4) BRAFi; 5) NTRKi; 6) RETi,

4. Chronic inflammatory liver condition. History or clinical evidence of any liver orbiliary pathology including cirrhosis, infectious disease, inflammatory conditions,steatosis, or cholangitis (including ascending cholangitis, primary sclerosingcholangitis, obstruction, perforation, fistula of biliary tract, spasm of sphincterof Oddi, biliary cyst or biliary atresia).

5. Prior organ or stem cell transplant.

6. Known active infection with HIV, HTLV-1, hepatitis B virus (HBV), or hepatitis Cvirus (HCV):

7. Patients with a history of hepatitis B or C are allowed if HBV DNA or HCV RNAare undetectable,

8. Active infection with human immunodeficiency virus (HIV) and CD4+ T-cell count <350/μL. Patients not on established ART for at least four weeks and having adetectable HIV viral load.

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 CNS primary tumor or metastases and/or carcinomatous meningitis.Patients with previously treated brain metastases may participate provided they areclinically stable for at least 4 weeks prior to first dose of study drug, have noevidence of new or enlarging brain metastases and are off steroids for at least 15days prior to first dose of study drug.

11. Known history of a hematologic malignancy, malignant primary brain tumor, or of asecond malignant primary solid tumor (other than that under study), unless thepatient has undergone potentially curative therapy with no evidence of that diseasefor 3 years. Note: The time requirement for no evidence of disease for 3 years doesnot apply to patients who underwent successful definitive resection of non-melanomaskin cancer, superficial bladder cancer, in situ cervical cancer, or other in situcancers.

12. Active infection requiring therapy. However, subject with minor infections whereoral antibiotic required, (e.g., urinary tract infection, Upper respiratory tractinfection, 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. Received an investigational product or been treated with an investigational devicewithin 30 days prior to first drug administration.

15. Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents ortyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) ofthe start of study treatment; immunotherapy/monoclonal antibodies within 3 weeks ofthe start of study treatment; nitrosoureas, antibody-drug conjugates, or radioactiveisotopes within 6 weeks of the start of study treatment; 7-day washout is permittedfor palliative radiation (i.e. limited field, ≤ 14-day course of radiotherapy) tonon-CNS lesions.

16. 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.

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

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

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