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A Study of LP002 for the Treatment of Patients With Malignant Digestive System Neoplasms

NCT04755543 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2021-02-16

No results posted yet for this study

Summary

LP002 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. In this study, the safety, pharmacokinetics and preliminary efficacy of LP002 for the treatment of malignant digestive system neoplasms will be evaluated.

Conditions

  • Digestive System Neoplasms

Interventions

DRUG

LP002

600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W).

DRUG

Cisplatin

50mg/m2 IV on Day 1, Q2W

DRUG

Fluorouracil

2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W

BIOLOGICAL

OH2 oncolytic virus

106 or 107 or 108 CCID50/mL by intra-tumoral injection, Q2W

Sponsors & Collaborators

  • Taizhou HoudeAoke Biomedical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2021-06-30
Completion
2022-06-30

Countries

  • China

Study Locations

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Entities

Drugs

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 NCT04755543 on ClinicalTrials.gov