A Phase I/IIa, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Preliminary Anti-tumor Activity of H002 in Patients with Active Epidermal Growth Factor Receptor Mutation Locally Advanced or
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The purpose of this study is to evaluate the safety (the side effects) of H002, the study drug, and to determine the best dose of the drug to be given to patients. Another purpose is to find out the amount of study drug that is in your blood and how fast your body absorbs, metabolizes and eliminates the study drug from your body. This is the first study where H002 is being given to humans and it is not approved by the U.S. Food and Drug Administration (FDA).
Are you Eligible? (Inclusion Criteria)
- Must be 18 years old or older - Must have life expectancy 3 months or more - Cannot have or major surgery or traumatic injury within 4 weeks prior to treatment. If major surgery occurred more than 4 weeks prior, you must have recovered adequately.