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The Safety,Efficacy of Anti-EGFR Humanized Monoclonal Antibody Combined With Chemotherapy in Advanced Solid Tumors.

NCT03577704 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-04-12

No results posted yet for this study

Summary

HLX07 is a new anti-EGFR monoclonal antibody (mAb) with improved glycosylation pattern.In pre-clinical efficacy studies, HLX-07 is either equivalent or more potent than cetuximab in multiple cancer models without increased toxicities.This study is an open-labeled, dose-escalation study designed to explore the maximum tolerated dose (MTD) and safety of HLX07 in combination with different chemotherapy regimens.

Conditions

Interventions

DRUG

HLX07+Gemcitabine+Cisplatin

Recombinant anti-EGFR humanized monoclonal antibody in combination with Gemcitabine and Cisplatin. HLX07, IV, weekly.

DRUG

HLX07+Paclitaxel+Carboplatin

Recombinant anti-EGFR humanized monoclonal antibody in combination with Paclitaxel and Carboplatin. HLX07, IV, weekly.

DRUG

HLX07+mFOLFOX6

Recombinant anti-EGFR humanized monoclonal antibody in combination with Oxaliplatin, Calcium Folinate and 5-FU. HLX07, IV, weekly.

Sponsors & Collaborators

Principal Investigators

  • Jin E Li, PhD · No.1800 Yuntai Road,Pudong District,Shanghai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2018-08-08
Primary Completion
2022-09-30
Completion
2022-12-30

Countries

  • China

Study Locations

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Entities

Diseases
Companies

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 NCT03577704 on ClinicalTrials.gov