An Open-label, Phase 1 Study to Determine the Maximum Tolerated Dose of HLX07,in Patients With Advanced Solid Cancers
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|ClinicalTrials.gov Identifier: NCT02648490|
Recruitment Status : Completed
First Posted : January 7, 2016
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumour||Drug: HLX07 Drug: Acetaminophen Drug: dexamethasone Drug: diphenhydramine Drug: 5-HT3 inhibitor||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, open-label, dose-escalation study of HLX07 ,3+3 design|
|Masking:||None (Open Label)|
|Official Title:||A Prospective,Open-label, Dose Escalation Phase 1 Study to Investigate the Safety, and Tolerability and to Determine the Maximum Tolerated Dose and Recommended Phase 2 Dose of a HLX07, in Patients With Advanced Solid Cancers.|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||June 28, 2019|
|Actual Study Completion Date :||June 28, 2019|
Experimental: HLX07, in patients with solid cancers.
Each cycle of treatment consists of 4 weeks. Patients who enroll into this study will receive weekly infusion of assigned dose of HLX07. No intra-patient dose escalation is allowed.The proposed dose escalation sequence is 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg.
Acetaminophen 500 mg PO 30 minutes before the infusion of HLX07, followed by dexamethasone 10 mg intravenous infusion for 10 minutes, and followed by diphenhydramine 30 mg intravenous infusion for 10 minutes. 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.
recombinant human anti-EGFR monoclonal antibody against cancers
Other Name: anti-EGFR monoclonal antibody
Acetaminophen 500 mg PO 30 minutes before the infusion of HLX07.
Other Name: Tylenol
dexamethasone 10 mg intravenous infusion for 10 minutes before the infusion of HLX07.
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.
Other Name: Ondansetron
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 1 year ]
- Number of participants with treatment-related pathological Complete Response assessed using RECIST 1.1 criteria. [ Time Frame: 1 year ]Patients will receive CT/MRI imaging studies every 8 weeks for treatment response until disease progression, withdrawal from the study or death, whichever occurs first.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02648490
|United States, California|
|Fremont, California, United States, 94538|
|Linkou Chang Gung Memorial Hospital|
|Principal Investigator:||Weidong Jiang, Ph.D.||Henlix, Inc|