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Study of RC48-ADC in Patients With HER2-Positive Advanced Malignant Solid Tumors

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ClinicalTrials.gov Identifier: NCT02881138
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
RemeGen

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: RC48-ADC Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2015
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: RC48-ADC
The phase I component has several dose levels of RC48-ADC (0.5 mg/kg, 1.0mg/kg, 1.5mg/kg, 2.0mg/kg, 2.5mg/kg, 3.0mg/kg, 3.5mg/kg, 4.0 mg/kg and 4.5 mg/kg) and is designed as a traditional dose-escalation study.Determine the recommended Phase II doses and regimens of RC48-ADC. Dosing interval is once two weeks.
Drug: RC48-ADC



Primary Outcome Measures :
  1. maximal tolerance dose (MTD) of RC48-ADC [ Time Frame: DLT will be evaluated on Day 21 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 Outcome Measures :
  1. Safety (the drug safety as assessed by NCI-CTCAE v4.0) [ Time Frame: Up to 1 years ]
    The drug safety as assessed by NCI-CTCAE v4.0



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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;
    • platelets>=70*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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881138


Contacts
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Contact: Lin Li 86-010-58075563 hnanlilin@163.com
Contact: Xu

Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Binghe Xu         
Sponsors and Collaborators
RemeGen
Investigators
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Principal Investigator: Binghe Xu Cancer Institute and Hospital, Chinese Academy of Medical Sciences

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Responsible Party: RemeGen
ClinicalTrials.gov Identifier: NCT02881138     History of Changes
Other Study ID Numbers: C001 CANCER
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided