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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03869697
Registration number
NCT03869697
Ethics application status
Date submitted
1/03/2019
Date registered
11/03/2019
Date last updated
2/02/2022
Titles & IDs
Public title
Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Pleural Effusions
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Scientific title
A Phase I Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetics of SCB-313, a Fully-Human TRAIL-Trimer Fusion Protein, for the Treatment of Malignant Pleural Effusions
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Secondary ID [1]
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CLO-SCB-313-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Malignant Pleural Effusions
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Cancer
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Other cancer types
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SCB-313
Experimental: SCB-313 - Cohorts in SAD phase: 5 mg, 10mg, 20mg, 40mg, 80 mg. Cohort in MAD phase: biological effective dose determined from SAD phase. 1 intrapleural injection of SCB-313 on Day 1 for the SAD cohorts, and 3 intrapleural injections of SCB-313 on Days 1, 2 and 3 for the MAD cohort.
Treatment: Drugs: SCB-313
5 mg or 20 mg lyophilized powder in a single-use glass vial
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Occurrence of DLT
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Assessment method [1]
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Occurrence of dose limiting toxicity (DLT)
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Timepoint [1]
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Up to 21 days after start of treatment
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Secondary outcome [1]
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SAEs or TEAEs
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Assessment method [1]
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Occurrence of serious adverse events (SAEs) and/or treatment-emergent adverse events (TEAEs) regardless of causality or relationship to SCB-313, graded using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03
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Timepoint [1]
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Up to 21 days after start of treatment
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Secondary outcome [2]
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Immunogenicity
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Assessment method [2]
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Occurrence of binding and neutralizing anti-SCB-313 antibodies
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Timepoint [2]
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Up to 21 days after start of treatment
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Secondary outcome [3]
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Pleural effusion response rate at Day 21
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Assessment method [3]
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Based on chest radiographs at Day 21, compared to Baseline.
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Timepoint [3]
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At Day 21 after start of treatment
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Secondary outcome [4]
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Pleural effusion drainage-free rate at Day 21
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Assessment method [4]
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Defined as the probability of being effusion-drainage free at Day 21
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Timepoint [4]
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At Day 21 after start of treatment
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Secondary outcome [5]
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The changes in effusion volume and flow rate after SCB-313 treatment , and at next drainage over the baseline daily effusion flow rate.
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Assessment method [5]
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The baseline daily effusion flow rate will be measured.
Effusion flow rate will be calculated from the effusion volume drained over the time elapsed between drainages.
Effusion flow rate at next pleural drainage will be calculated from the volume over the time elapsed between drainages.
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Timepoint [5]
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Up to 6 months after start of treatment
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Secondary outcome [6]
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Blood oxygen levels
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Assessment method [6]
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To compare blood oxygen levels during the study
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Timepoint [6]
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Up to 21 days after start of treatment
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Secondary outcome [7]
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Overall survival
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Assessment method [7]
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The time from the first dose of SCB-313 until death from any cause.
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Timepoint [7]
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Up to 6 months after start of treatment
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Secondary outcome [8]
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Pharmacokinetics (Cmax)
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Assessment method [8]
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Maximum SCB-313 concentration
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Timepoint [8]
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Up to 4 days after start of treatment
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Secondary outcome [9]
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Pharmacokinetics(Cmax/D)
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Assessment method [9]
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Dose-normalized Cmax of SCB-313
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Timepoint [9]
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Up to 4 days after start of treatment
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Secondary outcome [10]
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Pharmacokinetics(Tmax)
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Assessment method [10]
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Time to Cmax of SCB-313
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Timepoint [10]
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Up to 4 days after start of treatment
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Secondary outcome [11]
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Pharmacokinetics ([AUC]0-24)
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Assessment method [11]
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Area under SCB-313 concentration time curve from zero to 24 hours after dosing
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Timepoint [11]
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Up to 4 days after start of treatment
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Secondary outcome [12]
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Pharmacokinetics (AUC0-24/D)
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Assessment method [12]
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Dose-normalized AUC0-24
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Timepoint [12]
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Up to 4 days after start of treatment
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Secondary outcome [13]
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Pharmacokinetics ((AUC0-last))
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Assessment method [13]
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Area under the SCB-313 concentration-time curve from time zero to the last quantifiable concentration time point
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Timepoint [13]
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Up to 4 days after start of treatment
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Secondary outcome [14]
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Pharmacokinetics (Ctrough)
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Assessment method [14]
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Trough concentration (Ctrough) at each predose time point and at 24 hours after the last dose
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Timepoint [14]
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Up to 4 days after start of treatment
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Secondary outcome [15]
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Amount of drug in pleural effusion
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Assessment method [15]
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Amount of SCB-313 in pleural effusion at 24 hours after each dose
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Timepoint [15]
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Up to 4 days after start of treatment
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Secondary outcome [16]
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Pharmacokinetics (AUC 0-inf)
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Assessment method [16]
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Area under the curve from time zero extrapolated to infinity
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Timepoint [16]
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Up to 4 days after start of treatment
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Secondary outcome [17]
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Pharmacokinetics (AUC0-inf/D)
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Assessment method [17]
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Dose-normalized AUC0-inf
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Timepoint [17]
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Up to 4 days after start of treatment
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Secondary outcome [18]
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Pharmacokinetics (t1/2)
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Assessment method [18]
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Terminal half-life
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Timepoint [18]
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Up to 4 days after start of treatment
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Secondary outcome [19]
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Pharmacokinetics (CL/F serum only)
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Assessment method [19]
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Apparent systemic clearance after intrapleural dosing
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Timepoint [19]
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Up to 4 days after start of treatment
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Secondary outcome [20]
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Pharmacokinetics (Vz/F serum only)
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Assessment method [20]
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Apparent volume of distribution after intrapleural dosing
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Timepoint [20]
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Up to 4 days after start of treatment
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Secondary outcome [21]
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Pharmacokinetics (?z)
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Assessment method [21]
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Terminal rate constant
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Timepoint [21]
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Up to 4 days after start of treatment
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Secondary outcome [22]
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Tumor response
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Assessment method [22]
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Tumor response in patients with measurable disease using RECIST v1.1 as applicable.
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Timepoint [22]
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Up to 6 months after start of treatment
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Secondary outcome [23]
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Carcinoembryonic antigen (CEA)
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Assessment method [23]
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Changes in serum tumor markers
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Timepoint [23]
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Up to 21 days after start of treatment
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Secondary outcome [24]
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CA-125
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Assessment method [24]
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Changes in serum tumor markers
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Timepoint [24]
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Up to 21 days after start of treatment
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Secondary outcome [25]
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CA-19-9
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Assessment method [25]
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Changes in serum tumor markers
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Timepoint [25]
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Up to 21 days after start of treatment
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Secondary outcome [26]
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Changes in 24-hour urine volume
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Assessment method [26]
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Measured urine volume at baseline and postdose
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Timepoint [26]
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Up to 4 days after start of treatment
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Secondary outcome [27]
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Changes in GFR
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Assessment method [27]
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The changes in glomerular filtration rate
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Timepoint [27]
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Up to 4 days after start of treatment
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Secondary outcome [28]
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Changes in tumor cell count in pleural effusion samples
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Assessment method [28]
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The changes in tumor cell count
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Timepoint [28]
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Up to 4 days after start of treatment
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Secondary outcome [29]
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Caspase-cleaved CK18
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Assessment method [29]
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Changes in serum PD biomarker
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Timepoint [29]
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Up to 10 days after start of treatment
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Secondary outcome [30]
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KRAS mutation
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Assessment method [30]
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Predictive biomarker analysis (assessed using archival tumor specimens )
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Timepoint [30]
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Baseline
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Secondary outcome [31]
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MMR defects
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Assessment method [31]
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Predictive biomarker analysis (assessed using archival tumor specimens )
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Timepoint [31]
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Baseline
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Secondary outcome [32]
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Bcl2 overexpression
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Assessment method [32]
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Predictive biomarker analysis (assessed using archival tumor specimens )
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Timepoint [32]
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Baseline
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Secondary outcome [33]
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TRAIL resistance
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Assessment method [33]
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Predictive biomarker analysis (assessed using pleural effusion samples)
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Timepoint [33]
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Baseline
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Eligibility
Key inclusion criteria
1. Histologically or cytologically confirmed cancer of any primary tumor type.
2. Malignant pleural effusion causing respiratory symptoms requiring drainage that is
histologically or cytologically confirmed; or pleural effusion with radiologically
proven pleural malignancy as diagnosed in normal clinical practice on thoracic
computed tomography in the absence of histocytological or cytological proof.
3. 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.
4. Life expectancy of at least 8 weeks.
5. Age =18 years.
6. Adequate hematologic function, defined as:
1. Platelet count =75,000/µL;
2. Prothrombin time and activated partial thromboplastin time =1.5 times the upper
limit of normal (ULN);
3. Absolute neutrophil count =1,500 µL;
4. 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).
7. Adequate renal function, defined as creatinine clearance >40 mL/minute.
8. Adequate liver function, defined as:
1. Aspartate aminotransferase and alanine aminotransferase =2.0 times ULN;
2. Bilirubin =2.0 times ULN, unless patient has known Gilbert's syndrome.
9. Female patients of childbearing potential (excluding women who have undergone surgical
sterilization or are menopausal, defined as no menstrual periods for 1 year or more
without any other medical reasons) are eligible if they have negative serum pregnancy
test result 7 days before the first dose of SCB-313 and are willing to use an
effective method of birth control/contraception to prevent pregnancy until 6 months
after discontinuation of SCB-313.
Both men and women of reproductive potential must agree to use effective contraception
during the study and for 6 months after discontinuation of SCB-313.
Note: Contraceptive methods that are considered highly effective areas follows: total
abstinence, intrauterine device, double barrier method (such as condom plus diaphragm
with spermicide), contraceptive implant, hormonal contraceptives (contraceptive pills,
implants, transdermal patches, hormonal vaginal devices, or injections with prolonged
release), or vasectomized partner with confirmed azoospermia.
10. Willing to attend follow-up visits on Days 10, and 21 after the first study drug
administration.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Significantly loculated pleural effusions not amenable to drainage or patient is
unlikely to benefit from intrapleural therapy.
2. Concurrent use of any investigational product (IP) or investigational medicine within
28 days before Day 1 of study drug administration.
3. Radiotherapy outside the chest field within 2 weeks, or radical radiotherapy to
pleural or lung lesions within 8 weeks prior to enrollment (Note: palliative
radiotherapy to the chest is allowed).
4. Start a new systemic anticancer therapy, including chemotherapy, targeted therapy,
immuno-oncology (I-O) therapy regimen, within 28 days before Day 1 of study drug
administration or during DLT observation period.
5. Acute or chronic infection (such as tuberculosis) requiring antiviral or intravenous
antibiotics within 2 weeks prior to enrollment.
6. Clinical unstable or uncontrolled concomitant hematologic, cardiovascular, pulmonary,
hepatic, renal, pancreatic, or endocrine diseases.
7. History of gross hemoptysis (>2.5 mL).
8. Residual adverse events (AEs) > Grade 2 from previous treatment.
9. Evidence or suspicion of relevant psychiatric impairment, including alcohol or
recreational drug abuse.
10. 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 >480 msec at Baseline.
11. 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).
12. Major surgery (open procedures) within 4 weeks prior to enrollment.
13. Patient with ileus within 30 days prior to Screening.
14. Positive serology test for human immunodeficiency virus type 1 and/or 2, or known
history of other immunodeficiency disease.
15. Live vaccine within 2 weeks prior to enrollment.
16. Scheduled participation in another clinical study involving an investigational product
or device during the DLT observation period of this study.
17. Previous treatment with a TRAIL-based therapy or death receptor 4/5 agonist therapy.
18. Known or suspected hypersensitivity to any component of SCB-313.
19. Any further condition which, in the opinion of the Investigator, may result in undue
risk of the patient by participating in the present study.
20. Untreated central nervous system metastatic disease, leptomeningeal disease, or cord
compression.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
20/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/11/2021
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Sample size
Target
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Accrual to date
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Final
5
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Liverpool Hospital - Liverpool
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Recruitment hospital [2]
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Orange Health Service - Orange
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Recruitment hospital [3]
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The Royal Melbourne Hospital - Parkville
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Recruitment hospital [4]
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SCGH (Sir Charles Gairdner Hospital) - Nedlands
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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2800 - Orange
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Recruitment postcode(s) [3]
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3050 - Parkville
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Clover Biopharmaceuticals AUS Pty Ltd
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and
PK/PD of SCB-313 (recombinant human TRAIL-Trimer fusion protein) administered once via
intrapleural injection (SAD) and once daily over 2 to 3 days (MAD)for the treatment of cancer
patients with symptomatic malignant pleural effusions requiring drainage.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03869697
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03869697
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