To Evaluate the Efficacy and Safety of CAN008 Combined With Re-irradiation (rRT) for Treating Patients With Recurrent Glioblastoma (GBM)

NCT03746288 | Unknown Phase 2

• 1 other identifier: CAN-B1-008-L-005
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, randomized, controlled study, aiming to evaluate the efficacy and safety of CAN008 administered once-weekly with rRT for treating first tumor recurrence in patients with GBM.

Conditions

GBM

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From date of randomization until the date of death from any cause,assessed up to 12 months

Secondary Outcomes (4)

• Progression free survival (PFS)

  "From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

• 6-month progression free survival rate (PFS6)

  The percentage of subjects confirmed without PD or death at 6 months after randomization.

• Objective response rate (ORR)

  rom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months").

• Duration of response (DOR)

  rom date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months").

Study Arms (2)

Treatment Group

EXPERIMENTAL

CAN008 400 mg weekly over no less than 30 minutes via intravenous drip, followed by rRT that same day

Drug: CAN008

Control Group

ACTIVE COMPARATOR

The dose is 2.0 Gy/d, 5 times/week, with a total planned radiation dose of 36 Gy.

Drug: CAN008

Interventions

CAN008 DRUG

CAN008 400 mg weekly over no less than 30 minutes via intravenous drip, followed by rRT that same day

Also known as: Radiation

Control Group; Treatment Group

Eligibility Criteria

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

You may qualify if:

• Subjects with histologically diagnosed GBM confirmed by pathological tests at the central laboratory;
• Subjects who have definite CD95L IHC expression level and CD95L methylation level results confirmed at the central laboratory;
• Subjects with GBM who are not suitable for surgical ablation after tumor recurrence or have residual neoplasm after surgical ablation;
• Patients with disease progression or recurrence based on RANO (Response Assessment in Neuro-oncology) Criteria identified upon magnetic resonance imaging (MRI) performed two weeks prior to the first dose of investigational drug and two weeks prior to the initiation of rRT;
• Age ≥ 18 years and ≤ 70 years;
• Expected survival ≥ 3 months;
• Karnofsky score ≥60;
• Subjects who have tumor progression after having previously received standard treatments including surgery, chemoradiation combination (RT+ TMZ), adjuvant chemotherapy (TMZ);
• Subjects who have a single primary lesion or have scattered or multiple lesions which can be contained within a radiation target volume;
• Subjects who have received a maximum dose of 60 Gy for a single tumor in situ in the previous RT, or have not received RT for at least 8 months;
• Subjects eligible to receive rRT who have recurrence of tumor in situ on the T1-weighted MRI (T1-MRI) (Gd), with the maximum diameter of 1-4 cm;
• Subjects who have appropriate hematologic parameters (absolute neutrophil count (ANC) ≥1.5×109/L, platelet count ≥80×109/L, hemoglobin (Hb)≥90 g/L), kidney function (serum creatinine≤1.25×ULN) and liver function (total bilirubin≤1. 5×ULN, AST≤2.5×ULN and ALT≤2.5×ULN);
• Subjects treated with hormone therapy must receive the treatment with steroid hormones at a stable dose or a reduced dose within 5 days before entering the trial;
• Female subjects of childbearing potential must have a negative serum HCG pregnancy test within 7 days before the first dose of investigational drug;
• Male and female subjects of childbearing potential must agree to adopt approved contraceptive methods (such as condoms and intrauterine ring) during the trial and till 3 months after the completion of this trial;

You may not qualify if:

• Subjects who have previously received more than one course of RT for the head or have received a total dose of \>60 Gy in the previous RT;
• Subjects who have received an accumulated radiation dose of \>54 Gy for the optic chiasma;
• Subjects whose scattered or multiple tumors cannot be included within a radiation target volume;
• Subjects who have previously received treatment with bevacizumab, iodine radiotherapy, gamma knife and/or brachytherapy;
• Subjects who cannot undergo MRI examination or follow-ups;
• Subjects with human immunodeficiency virus (HIV) infection;
• Subjects with active viral hepatitis need to be excluded:
• For those with inactive viral hepatitis, they can be considered to be enrolled in this trial if their liver function is within the allowable range, that is, hepatitis B virus deoxyribonucleic acid (HBV- DNA)\<2,000 IU/Ml;
• For those infected with hepatitis C virus (HCV), they can also be considered to be included if no HCV ribonucleic acid (HCV-RNA) is detected;
• Subjects who have hereditary fructose intolerance (HFI);
• Subjects whose previous history (such as serious coronary heart disease, serious diabetes, immune deficiency, sequelae of apoplexia, serious mental retardation, etc.) is considered to indicate poor prognosis, as evaluated by investigators;
• Pregnant and breast-feeding women;
• Subjects who suffer from any malignant tumors (except for basal cell carcinoma or cervical carcinoma in situ) at the same time. Those who have previously suffered from malignant tumors but have no evidences of disease recurrence for at least 5 years can still participate in this trial;
• Subjects who have participated in other clinical trials within 30 days prior to the enrollment or during the treatment phase of this trial;
• Subjects who has known coronary heart disease complicated by serious cardiac arrhythmias or heart failure (NYHA III-IV).

Sponsors & Collaborators

• CANbridge Life Sciences Ltd.: lead

MeSH Terms

Interventions

Radiation

Intervention Hierarchy (Ancestors)

Physical Phenomena

Central Study Contacts

Wenbin Li

CONTACT

86-010-67096611; neure55@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 19, 2018
• Study Start: November 20, 2018
• Primary Completion: July 1, 2021
• Study Completion: December 31, 2021
• Last Updated: November 19, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share