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A Study of RC48-ADC in Subjects With Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03052634
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
RemeGen

Brief Summary:
This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection in subjects with advanced breast cancer with HER2 positive or HER2 low expression

Condition or disease Intervention/treatment Phase
Advanced Breast Cancer Drug: RC48-ADC 1.5 mg/kg (HER2 Positive) Drug: RC48-ADC 2.0 mg/kg (HER2 Positive) Drug: RC48-ADC 2.5 mg/kg (HER2 Positive) Drug: RC48-ADC 2.0 mg/kg (HER2 Low Expression) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Study to Evaluate the Efficacy, Safety and Pharmacokinetics of RC48-ADC for Injection in Subjects With Advanced Breast Cancer With HER2 Positive or HER2 Low Expression
Actual Study Start Date : October 9, 2018
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: RC48-ADC 1.5 mg/kg (HER2 Positive) Drug: RC48-ADC 1.5 mg/kg (HER2 Positive)
15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 1.5 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.

Experimental: RC48-ADC 2.0 mg/kg (HER2 Positive) Drug: RC48-ADC 2.0 mg/kg (HER2 Positive)
15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 2.0mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.

Experimental: RC48-ADC 2.5 mg/kg (HER2 Positive) Drug: RC48-ADC 2.5 mg/kg (HER2 Positive)
15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 2.5 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.

Experimental: RC48-ADC 2.0 mg/kg (HER2 Low Expression) Drug: RC48-ADC 2.0 mg/kg (HER2 Low Expression)
45 advanced breast cancer participants with HER2 Low Expression will be treated with RC48-ADC at a dose of 2.0 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.




Primary Outcome Measures :
  1. RP2D [ Time Frame: Estimated 2 year ]
    Recommended Phase II Dose


Secondary Outcome Measures :
  1. Cmax [ Time Frame: Estimated 2 year ]
    Maximum Observed Plasma Concentration

  2. AUC [ Time Frame: Estimated 2 year ]
    Area Under Curve

  3. Tmax [ Time Frame: Estimated 2 year ]
    Time for Cmax

  4. Overall response Rate (ORR) [ Time Frame: Estimated 2 year ]
    As per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 - to estimate the anti-tumor activity of RC48-ADC.

  5. Clinical Benefit Rate (CBR) [ Time Frame: Estimated 2 year ]
    Clinical Benefit Rate was defined as the percentage of patients with complete remission (CR) partial remission (PR) stable (SD) not less than 4 months.

  6. Progression Free Survival (PFS) [ Time Frame: Estimated 2 year ]
    Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Voluntary signed informed consent;
  2. Female, aged between 18 to 70 years;
  3. ECOG performance status score of 0 or 1;
  4. Life expectancy greater than 12 weeks;
  5. Patients with locally advanced or metastatic breast cancer diagnosed by histology or cytology, and:

    1. Core cohort: standard treatment is ineffective (the disease progresses or has no remission after treatment) or cannot tolerate standard treatment, or HER2 positive who cannot receive standard treatment (immunohistochemistry is 2+ and confirmed by fluorescence in situ hybridization [FISH] Positive, or immunohistochemical 3+) patients;
    2. Explorative cohort:standard treatment is ineffective (the disease progresses or has no remission after treatment) or cannot tolerate standard treatment, or had no optional standard treatment for HER2 immunohistochemistry 2+ with FISH negative or HER2 immunohistochemistry 1+ (FISH negative or untested). Subjects in the explorative cohort can provide HER2 detection of tumor primary or metastatic site specimens;
  6. Measurable lesion according to the RECIST 1.1;
  7. Adequate organ function:

(1)absolute neutrophil count(ANC) >= 1.5 x 10(9)/L; (2) platelets>=100*10(9)/L; (3)Total serum bilirubin <=1.5*ULN; (4)serum aspartate transaminase (AST)and serum alanine transaminase (ALT) <=2.5*ULN, or AST and ALT<=5*ULN with hepatic metastasis; (5) Serum creatinine clearance rate >= 45 mL/min; (6) INR<=1.5*ULN and APTT<=1.5*ULN; 8.Women of child-bearing potential and men must agree to use adequate contraception (e.g., condoms, implants, injectables, combined oral contraceptives, some intrauterine devices, 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; 9.Left ventricular ejection fraction (LVEF) >= 50%.

Exclusion Criteria:

  1. Women who are pregnant (positive blood test before medication) or breastfeeding;
  2. Patients received anti-cancer therapy within 4 weeks before study drug treatment;, including chemotherapy, radiotherapy, surgery or hormone therapy, molecular targeted therapy (including trastuzumab etc.); Using Trastuzumab emtansine(T-DM1) or participating in the clinical trial on ADC drugs targeting HER2 and bispecific antibodies targeting HER2;
  3. The patient have third interstitial fluid (a large number of pleural effusion or ascites) which has clinical symptom or can not be controlled by drainage or other methods;
  4. Received Palliative radiation therapy for bone metastases within 2 weeks before study drug treatment;
  5. Toxicity of previous anti-tumor treatment has not recovered to CTCAE [version 4.0] 0-1, except for hair loss;
  6. Participated in other clinical trials within 4 weeks;
  7. Known hypersensitivity or delayed hypersensitivity to the some components of RC48-ADC or similar drugs;
  8. The active infection with clinical significance according to the researcher's judgment;
  9. Diagnosed with HBsAg or HBcAb positive and HBV DNA positive, or HCV Ab positive, or HIV Ab positive.
  10. Have a history of immunodeficiency, including a positive HIV test, or other acquired, congenital immunity Epidemic defects, or a history of organ transplantation;
  11. Uncontrolled systemic diseases such as diabetes, hypertension, Pulmonary fibrosis, acute lung disease, interstitial lung disease, etc.
  12. Congestive heart failure with grade 2 or higher (including grade 2) of the New York Institute of Cardiology (NYHA) of the United States in the history of diseases such as acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within 6 months prior to entry ;
  13. Insufficient adherence to participate in this clinical study;
  14. 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 );
  15. Primary brain or metastatic tumor;
  16. Peripheral neuropathy with grade≥2;
  17. People with a history of mental illness that is difficult to control.

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): NCT03052634


Contacts
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Contact: Jianmin Fang +8610-58075763 jianminfang@hotmail.com

Locations
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China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Binghe Xu         
China
Affiliated cancer hospital of Harbin medical university Recruiting
Harbin, China
Contact: Qingyuan Zhang         
The fourth hospital of Hebei medical university Recruiting
Hebei, China
Contact: Yunjiang Liu         
Jiangsu Cancer Hospital Recruiting
Nanjing, China
Contact: Jifeng Feng         
Sponsors and Collaborators
RemeGen
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Responsible Party: RemeGen
ClinicalTrials.gov Identifier: NCT03052634    
Other Study ID Numbers: C003 CANCER
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases