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

NCT04123886 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-05-06

No results posted yet for this study

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

Interventions

DRUG

SCB-313

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 .

Sponsors & Collaborators

  • Sichuan Clover Biopharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-08
Primary Completion
2021-09-30
Completion
2022-03-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04123886 on ClinicalTrials.gov