A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis

Inclusion Criteria:

1. Be able to understand and voluntarily sign written informed consent.
2. Male or female subjects, age ≥18, ≤75 years.
3. Confirmed by histopathology or cytopathology, any primary or secondary malignantperitoneal carcinomatosis subject.
4. Progression after standard treatment, or inability to tolerate standard treatment, orno standard treatment.
5. ECOG status 0 to 2 or KPS status > 60
6. CT-PCI (Peritoneal Carcinomatosis Index) status ≥ 15
7. Life expectancy of at least 3 months.
8. No serious hematologic, hepatic, renal dysfunction, comply with the followinglaboratory test results:
9. Hematology: white blood cell count >3109/L, absolute neutrophil count ≥1.5109/L, platelets > 75*109/L, hemoglobin > 90 g/L.
10. Liver function: aspartate aminotransferase and alanine aminotransferase ≤ 3 timesULN, Alkaline phosphatase (ALP) ≤ 2.5 times ULN; serum total bilirubin (TBIL) ≤ 1.5 times ULN.
11. Renal function: Creatinine clearance calculated according to the Cockcroft-Gaultformula ≥ 50 mL/min.
12. All adverse events from previous system anticancer treatment return to baseline or ≤grade 1 (except for alopecia and vitiligo, neuropathy which induced by previousanticancer therapy status stable or ≤ grade 2).
13. Male or female subjects undergo effective contraception during treatment and within 6months after last dose.

Exclusion Criteria:

1. Previous treatment with TRAIL pathway drug.
2. Malignant cancer diseases other than malignant peritoneal carcinomatosis in this study (Exceptions include: a cured malignant cancer without relapse within 3 years prior tothe study enrollment, completely resected basal cells and squamous cell skin cancer,and any type of carcinoma in situ).
3. Primary lesion invades the central nervous system (CNS) with symptoms develop, statusunstable or require high dose steroids (e.g. dexamethasone ≥ 10 mg or equivalent dose)to control.
4. Abnormal HBV examination, anti-HCV positive, anti-HIV antibody positive or otherserious infections requiring systemic treatment within 4 weeks prior to first dosing (e.g. virus, bacteria or fungus).
5. Use the following concomitant therapy before dosing:
6. Use drug that prolongs the QT interval and/or associated with the risk oftorsades de pointes ventricular tachycardia (TdP) within 7 days prior to firstdosing.
7. Use amiodarone within 90 days prior to first dosing.
8. Impaired heart function or clinically significant cardiovascular disease, includingany of the following:
9. Cerebrovascular accident/stroke (within 6 months prior to enrollment).
10. Myocardial infarction (within 6 months prior to enrollment).
11. Unstable angina, congestive heart failure (New York Heart Association grade ≥ II)or severe arrhythmia requiring medication (including QT/QTc interval extension >480 msec, installation of pacemakers, etc.).
12. Left ventricular ejection fraction < 50% as determined by echocardiography.
13. Active bleeding history or gastrointestinal perforation risk within 4 weeks beforeenrollment, or not healed from recent surgery.
14. Received anticancer treatment within following specified time before first dosing:
15. Received medical treatment ≤ 4 weeks or 5 times known drug half-life (whicheveris longer).
16. Underwent major surgery within ≤ 4 weeks before first dosing.
17. Residual adverse events from previous treatment≥ grade 2.
18. Known to have alcohol and/or drug dependence.
19. Previous clear history of neurological or mental disorders, such as epilepsy, poorcompliance
20. Female subjects with positive blood pregnancy tests or during lactation.
21. Previously allergic to macromolecular protein drugs or proteins or Quincke's edema (Kunke edema, also known as angioedema) or allergic to any component of the SCB 313.
22. Known history of infection with human immunodeficiency virus, or other acquired,innate immune deficiency diseases, or history of organ transplantation.
23. Vaccination within ≤ 4 weeks prior to first dosing, or planning live vaccination.
24. For other reasons according to investigators, not suitable for participation in thetrial.