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.
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Full eligibility criteria for NCT02881138
Ages eligible for Study
18 Years to 65 Years
Genders eligible for Study
Accepts Healthy Volunteers
Signed informed consent form;
Aged 18-65 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;
Documented 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 (score, 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:
absolute neutrophil count(ANC) >= 1.5 x 10(9)/L;
Total serum bilirubin <=1.5*ULN;
serum aspartate transaminase (AST) and serum alanine transaminase (ALT)
<=3.0*upper limit of normal (ULN), or AST and ALT<=5*ULN if liver function abnormalities are due to underlying malignancy;
normal serum creatinine ;
international normalized ratio(INR) and activated partial thromboplastin time
(aPTT) must be less than or equal to 1.5 times the upper limit of the normal range (ULN);
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.
Current pregnancy or lactation;
Major surgery within 4 weeks of first dose of study drug and not fully recovered
receiving palliative radiation therapy for bone metastases if administered <= 2 weeks prior to first study treatment;
Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Event (CTCAE, version 4), grade less than or equal to1, or to the levels dictated in the inclusion/exclusion criteria with the exception of alopecia;
Prior-treatment with clinical research anticancer drugs within 28 days before study drug treatment;
Participated in clinical drug studies within 4 weeks;
receiving antineoplaston therapy including chemotherapy or radiotherapy , hormonal cancer therapy,biological therapy or immunotherapy within 4 weeks of starting study treatment,but excepting for the following treatment:
aiming at treatment of prostate cancer by gonadotropin releasing hormone (GnRH) antagonist ;
Hormone replacement therapy;
known hypersensitivity or delayed hypersensitivity to the some components of RC48-ADC or similar drugs;
the active infection with clinical significance according to the researcher's judgment;
Known history of immune deficiency,including HIV-positive or other known acquired or congenital immunodeficiency, or organ transplantation;
Currently active clinically significant cardiovascular disease such as uncontrolled arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study;
Unwilling or unable to participate in all required study evaluations and procedures;
the time interval which is from the last chemotherapy or HER2 targeted therapy until the first trial is more than 21 days;
Patients who had received systemic steroid therapy for a long time(Patients who had received systemic steroid therapy for short time and stopped drug more than 2 weeks could be enrolled);
Serious complications such as diabetes, interstitial pneumonia, pulmonary fibrosis, hypertension and Acute lung disease;
Patients using trastuzumab in the 60 days before the experiments;
Uncontrolled primary or metastatic tumor of brain;
Current peripheral neuropathy of Grade ≥ 2;
History of nerve or psychiatric disorders.
All locations for NCT02881138
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing, China, 100021
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Tris trial is registered with FDA with number: NCT02881138. The sponsor of the trial is RemeGen and it is looking for 50 volunteers for the current phase.
Official trial title:
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