Study of XNW28012 in Subjects with Advanced Solid Tumors Who Failed Standard Treatments

Inclusion Criteria:

1. For the dose escalation part: subjects with histologically or cytologicallyconfirmed advanced and/or metastatic solid tumors who have failed the establishedstandard anti-cancer therapies for a given tumor type or have been intolerant tosuch therapies.

2. For the dose expansion part: subjects must have a histological or cytologicaldiagnosis of progressive, locally advanced, and/or metastatic ovarian cancer,cervical cancer, pancreatic cancer, or colorectal cancer (CRC) who have failed thefollowing anti-cancer therapies: Ovarian cancer, Cervical cancer, Pancreatic cancer,Colorectal cancer.

3. Age ≥ 18 years old at the time of consent.

4. Subjects must have at least 1 measurable lesion as defined per RECIST version 1.1 (for dose expansion part only).

5. Subjects must have a performance status of 0 or 1 on the Eastern CooperativeOncology Group (ECOG) Performance Scale. ECOG status of 2 can be allowed if it is aresult of disease progression and warrants discussion with the medical monitor.

6. Subjects must have adequate organ function within 7 days prior to the first studydrug administration, as indicated by the flaboratory values:

7. Life expectancy of at least 12 weeks.

8. Females of childbearing potential must have a negative pregnancy test within 7 daysprior to the first dose of study drug. If the urine test is positive or cannot beconfirmed as negative, a serum pregnancy test will be required.

9. Non-sterile subjects must be willing to use a highly effective contraception (e.g.,IUD, pill, or condom) for the duration of the study and for 6 months after the lastdose of study drug unless their partner is sterilized.

10. Subjects are able to provide written informed consent, understand and are willing tocomply with the requirements of the study.

Exclusion Criteria:

1. A history of severe infusion reactions to other monoclonal antibodies/antibody drugconjugates (ADCs) or allergic reactions to any components of XNW28012.

2. Any anti-tumor therapy within 28 days prior to the first dose, including but notlimited to: small molecules, immunotherapy, chemotherapy, monoclonal antibodies, orany other experimental drugs.

3. Any active malignancy, with the exception of the specific types of cancers underinvestigation in this study and any locally recurring cancer that has been treatedcuratively .

4. Have received a live vaccine within 4 weeks prior to the first dose of study drug.Note: Seasonal vaccines for influenza are generally inactivated vaccines and areallowed; however, intranasal influenza vaccines will not be allowed if they areattenuated live vaccines.

5. Have received granulocyte colony stimulating factor (G-CSF) or granulocyte /macrophage colony stimulating factor support within 1 week before screening, orpegylated G-CSF within 2 weeks before screening.

6. Subjects with toxicities (as a result of prior anti-cancer therapy) which have notimproved to CTCAE grade ≤1 or stabilized, except those AEs not considered as alikely safety risk (e.g., alopecia).

7. Any history of intracerebral arteriovenous malformation, cerebral aneurysm, orstroke (transient ischemic attack) ≤ 3 months prior to screening is allowed ifstable.

8. Any of the hematological risk factors:

9. Subjects who are unwilling or unable to provide tumor tissue samples that meet therequirements for tissue factor (TF) expression testing.

10. Clinically significant cardiovascular/cerebrovascular conditions. 12. Active ocularsurface disease at screening, or subjects with any prior episode of cicatricialconjunctivitis.

11. Any history of Toxic Epidermal Necrolysis (TEN) or Steven Johnson Syndrome. 14.Subjects who have undergone major surgery within 28 days prior to the first dose ofstudy drug, except if the procedure is minimally invasive (for example, introductionof peripherally inserted central catheter [PICC] line).

and so on.