Newly Diagnosed GlioblastomaPhase 2NCT04600817
A Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients With Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT)
A Phase 2 study testing TJ107 in people with Newly Diagnosed Glioblastoma, run by TJ Biopharma Co., Ltd. at 16 sites in 2 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Newly Diagnosed Glioblastoma
- What is being tested?
- TJ107
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 31 Dec 2020to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form (ICF)
- Age ≥ 18 years and ≤70 years.
- 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)
- 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
- 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
- Karnofsky score ≥ 60
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- Life expectancy > 12 weeks
- 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
Who cannot join
- Subjects receiving 21 days hypofractionated radiotherapy due to clinical condition
- Multifocal glioma (≥3 lesions)
- Patients with primary subtentorial glioblastoma multiforme
- Patients who have evidence of leptomeningeal disease
- Patients on corticosteroid treatment have not a stable or decreasing dose for 14 days before randomization.
- Pregnancy, lactation, or breastfeeding (with lactation or breastfeeding required during the study period)
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- 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
- 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
- Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse
- 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)
- Anticipation of need for a major surgical procedure (requiring general anesthesia) during the study period
- 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
- 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)
- 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
- 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)
- 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
- 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.
- 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
- 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
- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- Severe infections within 2 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
- Prior allogeneic bone marrow transplantation or prior solid organ transplantation
- 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.
- 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."
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
China15 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing, 100050
Peking Union Medical College Hospital
Beijing
Chongqiong Cancer Hospital
Chongqing
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
Jiangsu Province Hospital
Nanjing, Jiangsu
Huashan Hospital Affiliated to Fudan University
Shanghai
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Shenzhen Second People's Hospital
Shenzhen, Guangdong
Tianjin Huanhu Hospital
Tianjin
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Tongji Hospital, Tongji Medical College of HUST
Wuhan, Hubei
Tangdu Hospital of The Fourth Military Medical University of Chinese PLA
Xi'an, Shaanxi
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
About this study
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)
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)
- Conditions
- Newly Diagnosed Glioblastoma
- Being tested
- TJ107, TJ107 placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TJ107Drug
QW8
TJ107 placeboDrug
QW8
| Study group | Role | What they receive |
|---|---|---|
| TJ107 | Experimental | Not described Receives: Drug: TJ107 |
| TJ107Placebo | Placebo comparator | Not described Receives: Drug: TJ107 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with average of ALC at 3w after first TJ107 dose and at pre-dose 3rd TMZ ≥1.5X109/L
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start31 Dec 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TJ Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600817
- Sponsor's protocol ID
- TJ107001GBM201
- Status last verified
- Apr 2024
- First submitted
- 19 Oct 2020
- Last updated
- 15 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04600817
- Acronym / sponsor ID
- TJ107001GBM201
- Conditions
- Newly Diagnosed Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- TJ Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TJ107 | Experimental | Drug: TJ107 |
| TJ107Placebo | Placebo comparator | Drug: TJ107 placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Signed Informed Consent Form (ICF)
- Age ≥ 18 years and ≤70 years.
- 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)
- 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
- 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
Key exclusion criteria (26 listed)
- Subjects receiving 21 days hypofractionated radiotherapy due to clinical condition
- Multifocal glioma (≥3 lesions)
- Patients with primary subtentorial glioblastoma multiforme
- Patients who have evidence of leptomeningeal disease
- Patients on corticosteroid treatment have not a stable or decreasing dose for 14 days before randomization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TJ107QW8 | Drug | TJ107 |
| TJ107 placeboQW8 | Drug | TJ107Placebo |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TJ107 in people with Newly Diagnosed Glioblastoma, run by TJ Biopharma Co., Ltd. at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.