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An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers

NCT02648490 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-07-30

No results posted yet for this study

Summary

This study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of humanized anti-EGFR monoclonal antibody, HLX07, in patients with epithelial cancer who have failed standard therapy and deemed unamenable by conventional therapy. This study will also evaluate the pharmacokinetics, pharmacodynamics, immunogenicity and anti-tumor effect of HLX07 and explore the potential prognostic and predictive biomarkers.

Conditions

  • Solid Tumour

Interventions

DRUG

HLX07

recombinant human anti-EGFR monoclonal antibody against cancers

DRUG

Acetaminophen

Acetaminophen 500 mg PO 30 minutes before the infusion of HLX07.

DRUG

dexamethasone

dexamethasone 10 mg intravenous infusion for 10 minutes before the infusion of HLX07.

DRUG

diphenhydramine

diphenhydramine 30 mg intravenous infusion for 10 minutes before the infusion of HLX07.

DRUG

5-HT3 inhibitor

If the patient experience grade 2 or 3 nausea and vomiting during the first infusion of HLX07, the addition of 5-HT3 inhibitor may be included in the premedication before subsequent infusions.

Sponsors & Collaborators

  • Henlix, Inc

    lead INDUSTRY

Principal Investigators

  • Weidong Jiang, Ph.D. · Henlix, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-06-28
Completion
2019-06-28

Countries

  • United States
  • Taiwan

Study Locations

More Related Trials

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 NCT02648490 on ClinicalTrials.gov