ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) and Advanced Solid Tumors

Inclusion Criteria:

• Subjects eligible for inclusion in this study must meet all of the followingcriteria:

1. Men or women greater than or equal to 18 years.

2. Locally advanced or metastatic solid tumors confirmed by histology or cytology,for which standard treatment is invalid, unavailable or intolerable.

3. At least one measurable lesion in accordance with RECIST 1.1.

4. Agree to provide fresh archival tumor tissue.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.

6. Estimated life expectancy ≥ 12 weeks.

7. Men or women should be using adequate contraceptive measures throughout thestudy.

8. Female subjects must not be pregnant at screening or have evidence ofnon-childbearing potential.

9. Signed and dated Informed Consent Form.

Exclusion Criteria:

• Any of the following would exclude the subject from participation in the study:

1. Treatment with any of the following:Previous or current treatment with B7-H3 targeted therapy. Any cytotoxicchemotherapy, investigational agents and anticancer drugs within 14 days priorto the first scheduled dose of HS-20093. Prior treatment with a monoclonalantibody within 28 days prior to the first scheduled dose of HS-20093.Radiotherapy with a limited field of radiation for palliation within 2 weeks,or patients received more than 30% of the bone marrow irradiation, orlarge-scale radiotherapy within 4 weeks prior to the first scheduled dose ofHS-20093.Pleural or peritoneal effusion requiring clinical intervention. Pericardialeffusion.Major surgery within 4 weeks prior to the first scheduled dose of HS-20093.Spinal cord compression or brain metastases. Treatment with drugs that arepredominantly strong inhibitors or inducers or sensitive substrates of CYP3A4,CYP2D6, P-gp or BCRP with a narrow therapeutic range within 7 days of the firstdose of study drug; or requiring treatment with these drugs during the study.Currently receiving drugs known to prolong QT interval or may cause torsade depointe; or requiring treatment with these drugs during the study

2. Patients with BRCA and ATM mutation.

3. Any unresolved toxicities from prior therapy greater than Grade 2 according toCommon Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exceptionof alopecia or neurotoxicity

4. History of other primary malignancies.

5. Inadequate bone marrow reserve or organ dysfunction.

6. Evidence of cardiovascular risk.

7. Severe, uncontrolled or active cardiovascular diseases.

8. Severe or uncontrolled diabetes, including diabetes ketoacidosis orhyperglycemia hypertonic occurring within 6 months before the first dose of thestudy drug, or the glycosylated hemoglobin value ≥ 7.5% in the screeningperiod.

9. Severe or poorly controlled hypertension.

10. Bleeding symptoms with apparent clinical significance or obvious bleedingtendency within 1 months prior to the first dose of HS-20093

11. Serious arteriovenous thrombosis events occurred within 3 months before thefirst dose

12. Severe infections occurred within 4 weeks before the first dose

13. Patients who have received continuous steroid treatment for more than 30 dayswithin 30 days before the first dose, or need long-term (≥ 30 days) steroidtreatment, or who have other acquired and congenital immunodeficiency diseases,or have a history of organ transplantation

14. The presence of active infectious diseases before the first dose such ashepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiencyvirus HIV infection, etc.

15. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or moresevere cirrhosis

16. Other moderate or severe urinary diseases that may interfere with the detectionor treatment of drug-related urinary toxicity or may seriously affect urinaryfunction.

17. History of serious neuropathy or mental disorders.

18. Women who are breastfeeding or pregnant or planned to be pregnant during thestudy period.

19. Vaccination or hypersensitivity of any level within 4 weeks prior to the firstdose of HS-20093

20. History of severe hypersensitivity reaction, severe infusion reaction orallergy to recombinant human or mouse derived proteins

21. Hypersensitivity to any ingredient of HS-20093

22. Unlikely to comply with study procedures, restrictions, and requirements in theopinion of the investigator.

23. Any disease or condition that, in the opinion of the investigator, wouldcompromise subject safety or interfere with study assessments.