A Study to Evaluate the Efficacy and Safety of TJ107 in Lympopenic Patients With Newly Diagnosed Glioblastoma Who Completed Standard Concurrent Chemoradiotherapy (CCRT)

NCT04600817 | Active Not Recruiting Phase 2

• 1 other identifier: TJ107001GBM201
• Study Type: interventional
• Target: 160
• Locations: 2 countries
• Sites: 16

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)

Conditions

Newly Diagnosed Glioblastoma

Outcome Measures

Primary Outcomes (1)

• The percentage of patients with average of ALC at 3w after first TJ107 dose and at pre-dose 3rd TMZ ≥1.5X109/L

  18 months

Study Arms (2)

TJ107

EXPERIMENTAL

Drug: TJ107

TJ107Placebo

PLACEBO COMPARATOR

Drug: TJ107 placebo

Interventions

TJ107 DRUG

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TJ107

TJ107 placebo DRUG

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TJ107Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• \*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)

Sponsors & Collaborators

• TJ Biopharma Co., Ltd.: lead

Study Sites (16)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

The Second Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Location

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Location

Tangdu Hospital of The Fourth Military Medical University of Chinese PLA

Xi'an, Shaanxi, China

Location

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100050, China

Location

Peking Union Medical College Hospital

Beijing, China

Location

Chongqiong Cancer Hospital

Chongqing, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, China

Location

Tianjin Huanhu Hospital

Tianjin, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 23, 2020
• Study Start: December 31, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CN (15); HK (1)