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Study With SCB-313 (Recombinant Human TRAIL-Trimer Fusion Protein) for Treatment of Malignant Ascites

NCT04051112 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2022-05-06

No results posted yet for this study

Summary

1. The safety and tolerability of single-dose of SCB-313 will be evaluated by intraperitoneal injection;
2. The safety and tolerability of repeated-dose of SCB-313 will be evaluated by intraperitoneal injection once a day for 3 days, and the maximum tolerated dose (MTD) of SCB-313 will be determined;

Conditions

  • Malignant Ascites

Interventions

DRUG

SCB-313

10mg group: Intraperitoneal injection single dose on Day 0, safety observation for 7 days, then 3 continuous doses on Day7, Day8, Day9, 21 days for 1 cycle

Sponsors & Collaborators

  • Sichuan Clover Biopharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-28
Primary Completion
2021-12-24
Completion
2022-04-21

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 NCT04051112 on ClinicalTrials.gov