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

Launched by SICHUAN CLOVER BIOPHARMACEUTICALS, INC. · Aug 6, 2019

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Eligibility criteria

• 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 malignant peritoneal carcinomatosis subject.
• • 4. Progression after standard treatment, or inability to tolerate standard treatment, or no 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 following laboratory test results:
• • 1. Hematology: white blood cell count \>3\*109/L, absolute neutrophil count ≥1.5\*109/L, platelets \> 75\*109/L, hemoglobin \> 90 g/L.
• • 2. Liver function: aspartate aminotransferase and alanine aminotransferase ≤ 3 times ULN, Alkaline phosphatase (ALP) ≤ 2.5 times ULN; serum total bilirubin (TBIL) ≤ 1.5 times ULN.
• • 3. Renal function: Creatinine clearance calculated according to the Cockcroft-Gault formula ≥ 50 mL/min.
• • 9. All adverse events from previous system anticancer treatment return to baseline or ≤ grade 1 (except for alopecia and vitiligo, neuropathy which induced by previous anticancer therapy status stable or ≤ grade 2).
• • 10. Male or female subjects undergo effective contraception during treatment and within 6 months 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 to the 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, status unstable 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 other serious 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:
• • 1. Use drug that prolongs the QT interval and/or associated with the risk of torsades de pointes ventricular tachycardia (TdP) within 7 days prior to first dosing.
• • 2. Use amiodarone within 90 days prior to first dosing.
• 6. Impaired heart function or clinically significant cardiovascular disease, including any of the following:
• • 1. Cerebrovascular accident/stroke (within 6 months prior to enrollment).
• • 2. Myocardial infarction (within 6 months prior to enrollment).
• • 3. 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.).
• • 4. Left ventricular ejection fraction \< 50% as determined by echocardiography.
• • 7. Active bleeding history or gastrointestinal perforation risk within 4 weeks before enrollment, or not healed from recent surgery.
• 8. Received anticancer treatment within following specified time before first dosing:
• • 1. Received medical treatment ≤ 4 weeks or 5 times known drug half-life (whichever is longer).
• • 2. Underwent major surgery within ≤ 4 weeks before first dosing.
• • 9. Residual adverse events from previous treatment≥ grade 2.
• • 10. Known to have alcohol and/or drug dependence.
• • 11. Previous clear history of neurological or mental disorders, such as epilepsy, poor compliance
• • 12. Female subjects with positive blood pregnancy tests or during lactation.
• • 13. 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.
• • 14. Known history of infection with human immunodeficiency virus, or other acquired, innate immune deficiency diseases, or history of organ transplantation.
• • 15. Vaccination within ≤ 4 weeks prior to first dosing, or planning live vaccination.
• • 16. For other reasons according to investigators, not suitable for participation in the trial.