Status:
TERMINATED
A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis
Lead Sponsor:
Sichuan Clover Biopharmaceuticals, Inc.
Conditions:
Peritoneal Carcinomatosis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
To evaluate the safety and tolerability of SCB-313 in patients with peritoneal carcinomatosisa, to determine the maximum tolerated dose (MTD) and/or extended study recommended dose (RDE) for SCB-313 i...
Eligibility Criteria
Inclusion
- Be able to understand and voluntarily sign written informed consent.
- Male or female subjects, age ≥18, ≤75 years.
- Confirmed by histopathology or cytopathology, any primary or secondary malignant peritoneal carcinomatosis subject.
- Progression after standard treatment, or inability to tolerate standard treatment, or no standard treatment.
- ECOG status 0 to 2 or KPS status \> 60
- CT-PCI (Peritoneal Carcinomatosis Index) status ≥ 15
- Life expectancy of at least 3 months.
- No serious hematologic, hepatic, renal dysfunction, comply with the following laboratory test results:
- Hematology: white blood cell count \>3\*109/L, absolute neutrophil count ≥1.5\*109/L, platelets \> 75\*109/L, hemoglobin \> 90 g/L.
- 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.
- Renal function: Creatinine clearance calculated according to the Cockcroft-Gault formula ≥ 50 mL/min.
- 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).
- Male or female subjects undergo effective contraception during treatment and within 6 months after last dose.
Exclusion
- Previous treatment with TRAIL pathway drug.
- 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).
- 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.
- 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).
- Use the following concomitant therapy before dosing:
- 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.
- Use amiodarone within 90 days prior to first dosing.
- Impaired heart function or clinically significant cardiovascular disease, including any of the following:
- Cerebrovascular accident/stroke (within 6 months prior to enrollment).
- Myocardial infarction (within 6 months prior to enrollment).
- 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.).
- Left ventricular ejection fraction \< 50% as determined by echocardiography.
- Active bleeding history or gastrointestinal perforation risk within 4 weeks before enrollment, or not healed from recent surgery.
- Received anticancer treatment within following specified time before first dosing:
- Received medical treatment ≤ 4 weeks or 5 times known drug half-life (whichever is longer).
- Underwent major surgery within ≤ 4 weeks before first dosing.
- Residual adverse events from previous treatment≥ grade 2.
- Known to have alcohol and/or drug dependence.
- Previous clear history of neurological or mental disorders, such as epilepsy, poor compliance
- Female subjects with positive blood pregnancy tests or during lactation.
- 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.
- Known history of infection with human immunodeficiency virus, or other acquired, innate immune deficiency diseases, or history of organ transplantation.
- Vaccination within ≤ 4 weeks prior to first dosing, or planning live vaccination.
- For other reasons according to investigators, not suitable for participation in the trial.
Key Trial Info
Start Date :
September 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04047771
Start Date
September 10 2019
End Date
May 5 2022
Last Update
April 12 2023
Active Locations (1)
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1
Beijing Shijitan Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100038