- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04047771
A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis
April 10, 2023 updated by: Sichuan Clover Biopharmaceuticals, Inc.
A Phase I Study Evaluating the Safety, Tolerability and Pharmacokinetics of SCB-313, Recombinant Human Tumor Necrosis Factor-Related Apoptosis-Inducing Ligand-Trimer Fusion Protein, for the Treatment of Subjects With Peritoneal Carcinomatosis
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 intraperitoneal injection, providing a basis for dosing regimen and dose choosing in clinical trial subsequently.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Beijing
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Beijing, Beijing, China, 100038
- Beijing Shijitan Hospital Capital Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SCB-313
|
Intraperitoneal injection, 3 doses on D1,D4,D7,21 days for 1 cycle
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Limiting Toxicity (DLT)
Time Frame: 21 days after first dosing
|
DLT
|
21 days after first dosing
|
Occurrence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame: 21 days after first dosing
|
AEs
|
21 days after first dosing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity
Time Frame: 28 days after last dosing
|
Occurrence of binding and neutralizing anti-SCB-313 antibodies
|
28 days after last dosing
|
Pharmacokinetics (Cmax)
Time Frame: Up to 24 hours after dosing
|
Maximum SCB-313 concentration
|
Up to 24 hours after dosing
|
Pharmacokinetics (tmax)
Time Frame: Up to 24 hours after dosing
|
Time to Cmax of SCB-313
|
Up to 24 hours after dosing
|
Pharmacokinetics ([AUC]0-24)
Time Frame: Up to 24 hours after dosing
|
Area under SCB-313 concentration time curve from zero to 24 hours
|
Up to 24 hours after dosing
|
Pharmacokinetics (AUC 0-inf)
Time Frame: Up to 24 hours after dosing
|
Area under curve from time 0 extrapolated to infinity
|
Up to 24 hours after dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 10, 2019
Primary Completion (Actual)
May 5, 2022
Study Completion (Actual)
May 5, 2022
Study Registration Dates
First Submitted
August 5, 2019
First Submitted That Met QC Criteria
August 6, 2019
First Posted (Actual)
August 7, 2019
Study Record Updates
Last Update Posted (Actual)
April 12, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CLO-SCB-313-CHN-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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