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Clinical Trial in Chinese Patients of Elapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma(GB226)

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ClinicalTrials.gov Identifier: NCT03623581
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Genor Biopharma Co., Ltd.

Brief Summary:
An open-label, single-arm, phase II clinical study of anti-PD-1 antibody GB226 in treatment of relapsed/metastatic/unresectable alveolar soft part sarcoma (ASPS)

Condition or disease Intervention/treatment Phase
Alveolar Soft Part Sarcoma Biological: GB226 Phase 2

Detailed Description:
GB226, 3mg/kg/time, is intravenously infused once every two weeks until disease progression, intolerable toxicity or study withdrawal decided by the investigator/subject. It is expected that each subject will be followed for 2 years. Subjects receiving GB226 treatment will be followed once every 2 weeks to the end of this study. If the patients terminate the treatment and their imaging assessment shows no progressive disease (PD), they should be followed once every 6 weeks until progressive disease (imaging evaluation). If the patients have progressive disease (imaging assessment), they should be followed every 3 months until the end of this study or premature withdrawal from the study. Relevant tests and evaluation should be completed at each visit according to standard of care. The follow-up visits can be performed by telephone. During the study, subjects must complete one imaging test and efficacy evaluation every 6 weeks until disease progression. Moreover, patients should be closely monitored for adverse events from subject enrollment to 30 days after the last dosing

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm, Phase II Clinical Study of Anti-PD-1 Antibody GB226 in Treatment of Relapsed/Metastatic/Unresectable Alveolar Soft Part Sarcoma (ASPS)
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : December 30, 2020


Arm Intervention/treatment
Experimental: GB226 3mg/kg every 2 weeks
GB226 3mg/kg every 2 weeks
Biological: GB226
3mg/kg treat every 2 weeks
Other Name: Recombinant humanized anti-PD-1 monoclonal antibody injection




Primary Outcome Measures :
  1. ORR [ Time Frame: up to 52 weeks ]
    Objective response rate in accordance with RECIST 1.1


Secondary Outcome Measures :
  1. PFS [ Time Frame: up to 52 weeks ]
    Progression-free survival

  2. DOR [ Time Frame: up to 52 weeks ]
    duration of response

  3. DCR [ Time Frame: up to 52 weeks ]
    disease control rate

  4. AE [ Time Frame: up to 52 weeks ]
    adverse event

  5. SAE [ Time Frame: up to 52 weeks ]
    serious adverse event



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signature of informed consent form;
  • Age of 18~75 years, male or female;
  • ECOG score: 0-1;
  • Expected survival >3 months;
  • Histologically or cytologically confirmed relapsed, metastatic or unresectable alveolar soft part sarcoma;
  • At least one measurable lesion, defined as a lesion of which the single diameter can be accurately measured (RECIST: longest diameter of non-lymph node lesion, short diameter of lymph node lesion);
  • At least 4 weeks after completion of previous treatment or at least 5 half lives of previous drug before administration of the drug (whichever is shorter) (at least 1 week between previous treatment and enrollment in the study), a washout period of at least 6 weeks for nitrosoureas, mitomycin C and RANKL inhibitors; at least 4 weeks after completion of the previous radiotherapy; at least 6 weeks after completion of previous treatment with other monoclonal antibodies;
  • If the patient has received a cumulative dose of doxorubicin above 350 mg/m2, a color Doppler ultrasound examination is required and the left ventricular ejection fraction (LVEF) shall be at least 50%;
  • Patients who have previously received CTLA-4 antibodies must meet the following conditions before they are allowed to participate in the study:

    i. At least 12 weeks after the last administration of drug; Ii. No history of severe immune-related adverse events (CTCAEV 4.03 G3 or G4);

  • Absolute neutrophil count ≥1.5x109/L, platelet count≥100x109/L, hemoglobin ≥80g/L;
  • Total bilirubin ≤1.5xULN (≤3xULN for patients with known Gilbert disease), AST/ALT≤3xULN (AST and/or ALT≤5xULNfor patients with liver metastasis), ALP≤2.5xULN (≤5xULN for patients with liver metastases or bone metastases);
  • Creatinine clearance≥50mL/min/1.73m2 (calculated by Cockcroft-Gault formula) or Cr≤1.5xULN; urinary protein <2+ or urinary protein quantification <1.0g/L;
  • Non-pregnant women identified within 72 hours before administration of drug; male or female subjects during the reproductive period who agree to take sufficient contraceptive measures prior to enrollment, during treatment, and within 6 months after the last dose;
  • Breastfeeding women who agree to stop breastfeeding during the study;
  • Consent to provide archived tumor tissue samples or fresh tissue samples

Exclusion Criteria:

  • History of treatment with anti-PD-1 or anti-PD-L1 monoclonal antibodies or drugs targeting related pathways;
  • Known allergy to PD-1 monoclonal antibody or any of its excipients; known history of allergic disease or severe allergic constitution;
  • The malignant tumors other than tumors treated in this study, except malignant tumors that were cured and did not relapse within 3 years prior to enrollment in the study, completely resected basal cells and squamous-cell carcinoma and any completely resected carcinoma in situ;
  • Active central nervous system metastasis (whether or not treated), including symptomatic brain metastasis, meningeal metastasis or spinal cord compression, except asymptomatic brain metastasis (no progression within at least 4 weeks after radiotherapy and/or no neurological symptoms or signs after resection, no need for dexamethasone or mannitol treatment).
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
  • Toxicity of the previous treatment > grade 1 (CTCAEV4.03 standard), except hair loss and neurotoxicity;
  • History of mental disorders;
  • History of drug addiction or drug abuse upon enquiry;
  • History of idiopathic pulmonary fibrosis or idiopathic pneumonia;
  • Comorbidities requiring treatment with immunosuppressive drugs, or comorbidities requiring systemic or topical use of corticosteroids at doses with immunosuppressive effects (prednisone >10 mg/day or the same class of drugs at an equivalent dose);
  • History of autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, except Type I Diabetes, hypothyroidism that can be controlled by hormone replacement therapy alone, skin diseases that do not require systemic treatment (such as vitiligo and psoriasis), controlled celiac disease, or diseases that are not expected to recur without external stimuli;
  • Past or present suffering from active tuberculosis infection;
  • Active infections requiring systemic treatment;
  • Uncontrolled hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg), pulmonary hypertension or unstable angina; myocardial infarction, bypass surgery or stent surgery within 6 months before administration of drug; History of chronic heart failure that meets the criteria for grade 3-4 defined by New York Heart Association (NYHA); clinically significant valvular disease; severe arrhythmia requiring treatment (excluding atrial fibrillation and paroxysmal supraventricular tachycardia), including QTc interval ≥450ms for male subjects and ≥ 470ms for female subjects (calculated by Fridericia formula); cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6 months before administration of drug;
  • Other serious medical conditions, including but not limited to uncontrolled diabetes, active peptic ulcer and active bleeding;
  • Positive anti-HIV, TP-Ab, HCV-Ab; positive HBV-Ag and copy number of HBV DNA > upper limit of normal in the test institution;
  • Abnormal results in thyroid function tests (FT3, FT4, T3, T4);
  • Expected major surgery within 28 days before or during treatment;
  • Live vaccines or attenuated vaccines are expected to be administered within 4 weeks before administration of drug, during treatment period or within 5 months after the last dose;
  • Participation in another clinical study and treatment with another study drug within 30 days prior to administration of the drug;
  • Need for RANKL inhibitors (such as denosumab);
  • Incapability of communication, understanding, and cooperation, poor compliance, and incapability of complying with the protocol;
  • Other reasons based on which the investigators believe that the subject is not suitable to participate in this clinical study.

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): NCT03623581


Contacts
Contact: Huiyang Cheng, Master 86-021-61690700 ext 55522 chenghuiyang@walvax.com
Contact: Junnan Li, Bachelor +86-18500533744 lijunnan@walvax.com

Locations
China, Beijing
Cancer Hospital Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100021
Contact: Yuankai Shi, Doctor         
Principal Investigator: Yuankai Shi, Doctor         
Sponsors and Collaborators
Genor Biopharma Co., Ltd.
Investigators
Principal Investigator: Yuankai Shi, Doctor Study Principal Investigator Cancer Hospital Chinese Academy of Medical Sciences

Responsible Party: Genor Biopharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT03623581     History of Changes
Other Study ID Numbers: Gxplore-005
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make individual participant data available.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Genor Biopharma Co., Ltd.:
ASPS

Additional relevant MeSH terms:
Sarcoma
Sarcoma, Alveolar Soft Part
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Muscle Tissue
Antibodies
Immunologic Factors
Physiological Effects of Drugs