A Phase I Study Evaluating SCB-313(Recombinant Human TRAIL-Trimer Fusion Protein) for the Treatment of Malignant Pleural Effusion

NCT04123886 | Completed Phase 1

• 1 other identifier: CLO-SCB-313-CHN-002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and tolerability of single dose of SCB-313 by intrapleural injection.To evaluate the safety and tolerability of repeated dose of SCB-313 by intrapleural injection once a day for 3 days, and to determine the maximum tolerated dose (MTD) of SCB-313.

Conditions

Malignant Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• DLT

  Dose Limiting Toxicity

  28 days after first dosing

Secondary Outcomes (2)

• AEs

  28 days after first dosing

• Immunogenicity

  up to 28 days after first dosing

Study Arms (1)

SCB-313

EXPERIMENTAL

Drug: SCB-313

Interventions

SCB-313 DRUG

SCB-313 Intrapleural injection, once daily. Single dose on Day 1 in Cycle 0 followed by 7-day safety assessment, then dose on Day 1,2,3 in Cycle 1 followed by 21-day observation .

SCB-313

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed cancer of any primary tumor type.
• Malignant pleural effusion requiring drainage that is histologically or cytologically confirmed;
• Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 2. Patients with an ECOG performance status of 3 may be included if the Investigator determines that removal of pleural fluid would improve their performance status to 2 or better.
• Life expectancy of at least 8 weeks.
• Age ≥18 years and ≤ 75 years;.
• Body weight ≥45 kg and body mass index ≥17 kg/m2.
• Adequate hematologic function, defined as:
• Platelet count ≥80,000/μL;
• Prothrombin time and activated partial thromboplastin time ≤1.5 times the upper limit of normal (ULN);
• Absolute neutrophil count ≥1,500 μL;
• Hemoglobin ≥8 g/dL (transfusion and erythropoietic agents are allowed). In case there is existence of active bleeding or other persistent condition of either increased destruction or impaired production of erythrocytes, which may require repeated transfusion or erythropoietic treatment, the eligibility must be discussed with the Sponsor on a case by-case basis prior to randomization.
• Ablumin≥35g/L
• Adequate renal function, defined as serum creatinine ≤2.0 times ULN and creatinine clearance \>50 mL/minute.
• Adequate liver function, defined as:
• Aspartate aminotransferase and alanine aminotransferase ≤2.0 times ULN for patients without liver metastases, or ≤5 times ULN in the presence of liver metastases;

You may not qualify if:

• Significantly loculated pleural effusions not amenable to drainage or patient is unlikely to benefit from intrapleural therapy.
• Any anti-tumor drug other than the systemic anti-tumor therapy that the subject has stably used and any treatment that may have an effect on the control of pleural effusions. Prior therapy with monoclonal antibody should be stopped per Investigators judgement making sure delayed side effects will not interfere with the DLT evaluation period after SCB-313 therapy.
• Acute or chronic infection (such as tuberculosis) requiring antiviral or intravenous antibiotics within 2 weeks prior to enrollment.
• Clinical unstable or uncontrolled concomitant hematologic, cardiovascular, pulmonary, hepatic, renal, pancreatic, or endocrine diseases.
• History of gross hemoptysis (\>2.5 mL) within 3 months prior to enrollment.
• Residual adverse events (AEs) \> Grade 2 from previous treatment.
• Evidence or suspicion of relevant psychiatric impairment, including alcohol or recreational drug abuse.
• Myocardial infarction within 6 months prior to treatment and/or prior diagnoses of congestive heart failure (New York Heart Association Class III or IV), unstable angina, unstable cardiac arrhythmia requiring medication, and/or long QT syndrome or QT/QTc interval \>450 msec at Baseline.
• Uncontrolled hypertension defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg confirmed upon repeated measures (note: no more than 3 repeated measures allowed).
• Major surgery (open procedures) within 4 weeks prior to enrollment.
• Patient with ileus within 30 days prior to Screening.
• Positive serology test for human immunodeficiency virus,Syphilis, Hepatitis B virus(HBV) and/or Hepatitis C virus(HCV).
• Live vaccine within 2 weeks prior to enrollment.
• Scheduled participation in another clinical study involving an investigational product or device during the DLT observation period of this study.
• Previous treatment with a TRAIL-based therapy or death receptor 4/5 agonist therapy.

Sponsors & Collaborators

• Sichuan Clover Biopharmaceuticals, Inc.: lead

Study Sites (1)

West China Hospitial, Sichuan University

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Pleural Effusion, Malignant

Condition Hierarchy (Ancestors)

Pleural Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Pleural Effusion; Pleural Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2019
• First Posted: October 11, 2019
• Study Start: January 8, 2020
• Primary Completion: September 30, 2021
• Study Completion: March 31, 2022
• Last Updated: May 6, 2022

Record last verified: 2022-05

Locations

CN (1)