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The primary objective is to evaluate the safety and, tolerabilitytolerance, pharmacokinetices and immunogenicity of escalating single doses and subsequent multiple dose of Gentuximab Injection in patients with late recurrence of metastatic solid tumors and to determine the maximum tolerated dose(MTD) and dose limiting toxicities(DLT).with single and subsequent multiple intravenous infusion in patients with late recurrence of metastatic solid tumors and to provide a basis for the protocol design of later clinical trials.
The secondary objective is to evaluate the pharmacokinetics, pharmacodynamics and immunogenicity, and tumor response of multiple dose of Gentuximab Injection in patients with late recurrence of metastatic solid tumors.
Full description
The safety profile of Gentuximab Injection will be explored together with the pharmacokinetics, pharmacodynamics and tumour response to treatment with Gentuximab Injection to recommend the dosing regimen for further clinical studies. The pharmacokinetic properties of Gentuximab Injection will be evaluated after single and multiple dose administrations at different dose levels.
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20 participants in 1 patient group
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Xiaohua Feng
Data sourced from clinicaltrials.gov
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