Status and phase
Conditions
Treatments
About
A tolerance, safety and pharmacokinetic ascending dose phase I Study of RC48-ADC administered intravenously to subjects with HER2-positive malignant in advanced malignant solid tumors.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Signed informed consent form;
Aged 18-75 years;
ECOG physical condition is 0 or 1;
Life expectancy greater than 12 weeks;
Patients with locally advanced or metastatic malignant solid tumors diagnosed by pathology and refractory to standard of care therapy, or for whom no standard of care therapy is available histology standard of care therapy, or for whom no standard of care therapy is available;
Human epidermal growth factor receptor 2 (HER2)-positive refers to immunohistochemistry (IHC 2+or 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% as assessed by echocardiogram.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
57 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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