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

PHASE1CompletedINTERVENTIONAL
Enrollment

19

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

June 28, 2019

Study Completion Date

June 28, 2019

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.

Trial Locations (2)

94538

Henlix, Inc., Fremont

Unknown

Linkou Chang Gung Memorial Hospital, Taoyuan District

All Listed Sponsors
lead

Henlix, Inc

INDUSTRY

NCT02648490 - An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers | Biotech Hunter | Biotech Hunter