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Trial record 1 of 1 for:    TJ107 | Glioblastoma Multiforme | China
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A Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients With Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT)

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: NCT04600817
Recruitment Status : Recruiting
First Posted : October 23, 2020
Last Update Posted : July 7, 2021
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.

Brief Summary:
A Phase 2, Randomized, Single-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients with Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT)

Condition or disease Intervention/treatment Phase
Newly Diagnosed Glioblastoma Drug: TJ107 Drug: TJ107 placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Single-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients With Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT)
Actual Study Start Date : December 31, 2020
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : February 28, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TJ107 Drug: TJ107
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Placebo Comparator: TJ107Placebo Drug: TJ107 placebo
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Primary Outcome Measures :
  1. The percentage of patients with average of ALC at 3w after first TJ107 dose and at pre-dose 3rd TMZ ≥1.5X109/L [ Time Frame: 18 months ]


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:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Informed Consent Form (ICF)
  2. Age ≥ 18 years and ≤70 years.
  3. Gross total resection equal to or greater than 80% based on post-op MRI, compared to pre-op MRI (Patients requiring biopsy only is not eligible)
  4. Patients newly diagnosed with glioblastoma either radiologically or pathologically and completed concurrent chemo-radiotherapy (CCRT) with plan to receive adjuvant temozolomide therapy with curative intent
  5. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the randomization.1) Absolute lymphocyte count (ALC) ≤1×109/L. 2) Absolute neutrophil count (ANC) ≥ 1.5×109/L. 3) Platelet count ≥ 100×109/L (without transfusion within 14 days prior to Cycle 1, Day 1). 4) Hemoglobin ≥ 9 g/dL Patients may be transfused or may receive erythropoietic treatment as per local standard of care. 5) Total bilirubin ≤ 1.5 × the upper limit of normal (ULN). 6) AST and ALT ≤ 3 × ULN. 7) Alkaline phosphatase ≤ 2.5 × ULN (For subject with proven liver or bone metastasis, alkaline phosphatase ≤ 5 × ULN is allowed). 8) Serum albumin ≥ 2.5 g/dL. 9) Serum creatinine ≤ 1.5 mg/dL. 10) Prothrombin time (PT) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. This applies only to patients who are not receiving therapeutic anticoagulation. Patients receiving therapeutic anticoagulation should be on a stable dose
  6. Karnofsky score ≥ 60
  7. Life expectancy > 12 weeks
  8. For women of childbearing potential*: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year from the date of informed consent to at least 3 months after the last dose of study drugs. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 3 months after the last dose of study treatment (TJ107) and 6 months after the last dose of temozolomide to avoid exposing the embryo. Men must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence and withdrawal are not acceptable methods of contraception.

    • A woman is of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
    • Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, and established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.
    • Hormonal contraceptive methods must be supplemented by a barrier method plus spermicide.
    • The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or post-ovulation methods) and withdrawal are not acceptable methods of contraception

Exclusion Criteria:

  1. Subjects receiving 21 days hypofractionated radiotherapy due to clinical condition
  2. Multifocal glioma (≥3 lesions)
  3. Patients with primary subtentorial glioblastoma multiforme
  4. Patients who have evidence of leptomeningeal disease
  5. Patients on corticosteroid treatment have not a stable or decreasing dose for 14 days before randomization.
  6. Pregnancy, lactation, or breastfeeding (with lactation or breastfeeding required during the study period)

    *Serum pregnancy test for women of childbearing potential (including women who have had a tubal ligation) must be performed and documented as negative within 14 days prior to randomization

  7. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, and/or unstable angina
  8. Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse
  9. Poorly controlled Type 2 diabetes mellitus defined as a screening hemoglobin A1C ≥ 8% or a fasting plasma glucose ≥ 160 mg/dL (or 8.8 mmol/L)
  10. Anticipation of need for a major surgical procedure (requiring general anesthesia) during the study period
  11. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension (defined by blood pressure higher than 150/90mmHg despite effective anti-hypertensive treatments) and active bleeding diatheses, which in the investigator's opinion makes it undesirable for the patient to participate in trial or which would jeopardize compliance with the protocol
  12. Any anti-cancer therapy, whether investigational or approved, including chemotherapy, immunotherapy, gene therapy, cancer vaccine, cell therapy, cytokines, hormonal therapy, and/or radiotherapy) received after standard concurrent chemo-radiotherapy (CCRT)
  13. Persisting toxicity related to prior therapy (NCI CTCAE v. 5.0 Grade > 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable
  14. Malignancies other than disease under study within 5 years prior to randomization except for those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ)
  15. Uncontrolled hypercalcemia (ionized Calcium > 1.5 mmol/L or Calcium > 12 mg/dL or adjusted serum Calcium ≥ ULN) or symptomatic hypercalcemia requiring bisphosphate or denosumab

    *Patients without history of clinically significant hypercalcemia, receiving either bisphosphonate or denosumab prophylactically is eligible

    ** Denosumab receiving patients should agree to switch to bisphosphate, and not contraindicated for bisphosphate use are eligible

  16. Patients with active virus infection requiring systemic treatment at screening 1) Positive test for HIV infection 2) Active HBV hepatitis: positive for HBsAg and HBV-DNA, if HBsAg positive but HBV-DNA negative during the screening can participate in the study.3) Active HCV hepatitis: positive for hepatitis C virus (HCV) antibody and HCV RNA. But the subject can be enrolled with serum anti-HCV positive and HCV RNA negative.
  17. Patients with autoimmune disease requiring treatment at the time of screening (appendix 3. List of autoimmune disease)1) Patients with adrenal or pituitary insufficiency requiring physiological dose of corticosteroid such as tyrosine, insulin. 2) Patients with leukoplakia, resolved pediatric asthma, atopic dermatitis, type 1 diabetic, hypothyroidism due to autoimmune disease only requiring hormone replacement therapy, psoriasis not requiring systemic treatment, and other disease status that recurrence nor exacerbations are not expected unless there is external contributing factors
  18. Administration of a live, attenuated vaccine within 14 days before randomization or anticipation that such a live attenuated vaccine will be required during the study.1) Measles, mumps, rubella, chickenpox, yellow fever, rabies, Bacillus Calmette-Guérin, BCG, herpes zoster, typhoid vaccines. 2) Seasonal influenza vaccine in injection formulation are generally not live vaccine, thus are allowed. Yet intra-nasal influenza vaccine such as Flumist® is attenuated live vaccine, thus is not allowed
  19. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  20. Severe infections within 2 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  21. Prior allogeneic bone marrow transplantation or prior solid organ transplantation
  22. Treatment with systemic immunosuppressive medications (including daily prednisone > 30mg, dexamethasone > 5mg, or equivalent dose of corticosteroid, cyclophosphamide, azathioprine, methotrexate, thalidomide, and TNF-α antagonists but not limited to) within 2 weeks prior to randomization. 1) Patients who acutely receives low dose immunosuppressive medication (e.g. daily prednisone ≤ 30 mg or daily dexamethasone ≤ 5 mg) can be enrolled upon approval from study medical monitor. 2) The use of inhaled corticosteroids (e.g., fluticasone for chronic obstructive pulmonary disease) is allowed. 3) The use of oral mineralocorticoids (e.g., fludrocortisone for patients with orthostatic hypotension) is allowed.
  23. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis * History of radiation pneumonitis in the radiation field (fibrosis) is allowed."

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): NCT04600817


Contacts
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Contact: Wenbin Li 15301377998 neure55@126.com
Contact: Zhuang Kang 15011281069 kzhaoren1984@163.com

Locations
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China, Guangdong
Shenzhen Second People's Hospital Recruiting
Shenzhen, Guangdong, China
Contact: Weiping Li    138 0883 4238      
China, Heilongjiang
Harbin Medical University Cancer Hospital Recruiting
Harbin, Heilongjiang, China
Contact: Jun Su    139 3619 8606      
China, Hubei
Tongji Hospital, Tongji Medical College of HUST Recruiting
Wuhan, Hubei, China
Contact: Guangyuan Hu    138 8600 0095      
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Yongping You    137 7069 4258      
China, Jiangxi
The Second Affiliated Hospital Of Nanchang University Recruiting
Nanchang, Jiangxi, China
Contact: Xingen Zhu    138 0354 6020      
China, Liaoning
Liaoning Cancer Hospital & Institute Recruiting
Shenyang, Liaoning, China
Contact: Haozhe Piao    189 0091 7766      
Shengjing Hospital of China Medical University Recruiting
Shenyang, Liaoning, China
Contact: Yunhui Liu    189 4025 1313      
China, Ningxia
General Hospital of Ningxia Medical University Recruiting
Yinchuan, Ningxia, China
Contact: Hechun Xia    139 9510 9559      
China, Shaanxi
Tangdu Hospital of The Fourth Military Medical University of Chinese PLA Recruiting
Xi'an, Shaanxi, China
Contact: Liang Wang    133 1923 2049      
China
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, China, 100050
Contact: Wenbin Li    15301377998    neure55@126.com   
Contact: Zhuang Kang    15011281069    kzhaoren1984@163.com   
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Wenbing Ma    137 0136 4566      
Chongqiong Cancer Hospital Recruiting
Chongqing, China
Contact: Run Cai    130 7234 1313      
Huashan Hospital Affiliated to Fudan University Recruiting
Shanghai, China
Contact: Jingsong Wu    137 0170 7118      
Tianjin Huanhu Hospital Recruiting
Tianjin, China
Contact: Wei Jiang    130 7220 1699      
Tianjin Medical University Cancer Institute & Hospital Recruiting
Tianjin, China
Contact: Wenliang Li    186 2222 1152      
Hong Kong
Prince of Wales Hospital Not yet recruiting
Hong Kong, Hong Kong
Contact: POONWai Sang         
Sponsors and Collaborators
I-Mab Biopharma Co. Ltd.
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Responsible Party: I-Mab Biopharma Co. Ltd.
ClinicalTrials.gov Identifier: NCT04600817    
Other Study ID Numbers: TJ107001GBM201
First Posted: October 23, 2020    Key Record Dates
Last Update Posted: July 7, 2021
Last Verified: July 2021
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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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue