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A Phase I Study to Evaluate the Safety,Tolerability and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Malignant Solid Tumors With HER2-positive
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed informed consent form;
Aged 18-65 years;
ECOG physical condition is 0 or 1;
Life expectancy greater than 12 weeks;
Diagnosed with histologically or cytologically-confirmed, standard treatment is ineffective (disease progresses after treatment) or HER2-positive, locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy;
Human epidermal growth factor receptor 2 (HER2)-positive as measured either by immunohistochemistry (IHC 2+ and by fluorescence in situ hybridization (FISH) or by immunohistochemistry (3+);
Patients with measurable and appreciable tumor lesions according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1);
Adequate organ function as defined by the following criteria:
Women of child-bearing potential and men must agree to use adequate contraception (e.g. condoms, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete sexual abstinence, or sterilized partner) prior to study entry and during the period of therapy and for 30 days after the last dose of study drug;
Left ventricular ejection fraction (LVEF) >= 50%.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
24 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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