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

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

2. Male or female ≥ 18 years of age or designated age of majority according to regulatory 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:

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

* Histological or cytological diagnosis of melanoma or any type of carcinoma or sarcoma,

* Refractory metastatic disease, or refractory locally advanced disease not amenable 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 with c-MET overexpression, MET amplification, or MET exon 14 skipping by local biomarker assessment as defined in study protocol. The number of patients with only c-MET overexpression is limited to 50% of enrolled patients in that dosing cohort including escalation and extension.

6. Progressive disease:

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

7. 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 disease per RECIST 1.1) with at least 1 radiological non-target lesion.

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

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

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

3. Hormonal female contraceptive (oral, parenteral, intravaginal, implantable or transdermal) for at least 3 consecutive months prior to investigational product administration (when not clinically contraindicated as in breast, ovarian and endometrial cancers),

4. Use of an intrauterine contraceptive device.

9. Resolution of prior-therapy-related AEs (including immune-related AEs but excluding alopecia) to ≤ Grade 1 per CTCAE, 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.

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

11. Minimum of \> 2 weeks or \> 5 half-lives (whichever is longer) between the start of study treatment since last dose of radiotherapy, chemotherapy, or molecularly targeted agents or tyrosine kinase inhibitors; minimum of \> 3 weeks of the start of study treatment since last dose of immunotherapy/monoclonal antibodies; \> 6 weeks of the start of study treatment since the last dose of nitrosoureas, antibody-drug conjugates or radioactive isotopes.

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

13. Tissue and/or blood specimens:

a. Phase 1: 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

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

14. If the patient agrees to optional pre- and/or study new tumor biopsies (that can be biopsied based on investigator's assessment) and to provide the tissue for biomarker analysis, a signed informed consent for the biopsy is required. Tissue obtained for the biopsy must not be previously irradiated. No systemic antineoplastic therapy may be received by the patient between the time of the biopsy and the first administration of ABN401.

For escalation, each dose escalation cohort must try to enroll at least 1 patient who agrees to biopsies. An exception to the requirement for a new tumor biopsy in at least one patient per dose level is that if the first patient in a single dose cohort 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-treatment FFPE tissue samples (unstained slides or blocks) or new frozen tissue may be provided for tumor analyses.

15. Able and willing to comply with the protocol and the restrictions and assessments therein.

What this study is about