Solid Tumors
Conditions
Brief summary
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.
Interventions
DRUGRC48-ADC
Sponsors
RemeGen Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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: * absolute neutrophil count(ANC) \>= 1.5 x 10(9)/L; * platelets\>=100\*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.
Exclusion criteria
* Current pregnancy or lactation; * Serologic status reflecting active hepatitis B or C infection; * 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Tolerance Dose (MTD) of RC48-ADC | DLT will be evaluated on Day 28 during cycle 1 | The dose level in which \>= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety (the drug safety as assessed by NCI-CTCAE v4.0) | up to 2 years | The drug safety as assessed by NCI-CTCAE v4.0 |
Countries
China
Outcome results
None listed