Back to resultsPhase 2 Study of CAN008 in Subjects With GBM
Primary Purpose
Newly-diagnosed Glioblastoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CAN008
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Newly-diagnosed Glioblastoma focused on measuring Glioblastoma, CAN008, APG101
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 70.
- Newly diagnosed glioblastoma.
- Tumor excision rate ≥80%.
- Karnofsky performance score ≥70.
Exclusion Criteria:
- Medical history of brain radiation therapy or electric field treatment of tumor.
- Primary infratentorial glioblastoma, multifocal glioma (≥ 2), or leptomeningeal metastasis.
- Any malignant tumor (excluding WHO grade I-II low-grade astrocytomas, basal cell carcinoma, and carcinoma in situ).
- Receiving high-dose hormone therapy.
Sites / Locations
- Beijing Tiantan Hospital, Capital Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CAN008
placebo
Arm Description
CAN008 IV infusion weekly
Placebo IV infusion weekly
Outcomes
Primary Outcome Measures
Progression-free survival (PFS)
To evaluate the efficacy of CAN008 plus temozolomide (TMZ) treatment in subjects with newly diagnosed glioblastoma (GBM) during and after radiation therapy
Secondary Outcome Measures
Overall survival (OS)
Overall survival (OS)
Full Information
NCT ID
NCT05447195
First Posted
June 17, 2022
Last Updated
July 10, 2022
Sponsor
CANbridge Life Sciences Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05447195
Brief Title
Phase 2 Study of CAN008 in Subjects With GBM
Official Title
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of CAN008 Plus TMZ During and After Radiation Therapy in Subjects With Newly Diagnosed Glioblastoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 10, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CANbridge Life Sciences Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled Phase 2 study whose objectives are to evaluate the clinical efficacy and safety of CAN008 plus TMZ during and after radiation therapy in newly-diagnosed subjects with glioblastoma who have undergone surgical excision.
Detailed Description
This study plans to enroll approximately 117 subjects. Subjects determined as having met inclusion criteria through screening will be randomized into treatment groups (CAN008 + RT + TMZ, 78 subjects) and the control group (placebo + RT + TMZ, 39 subjects) in a ratio of 2:1.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Newly-diagnosed Glioblastoma
Keywords
Glioblastoma, CAN008, APG101
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study is double-blinded. Except for the non-blinded team, no other participants associated with this study should attempt to learn the treatment group assignment or which study treatment they are receiving.The unblinding of all subjects must be carried out after the database is locked.
Allocation
Randomized
Enrollment
117 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CAN008
Arm Type
Experimental
Arm Description
CAN008 IV infusion weekly
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Placebo IV infusion weekly
Intervention Type
Drug
Intervention Name(s)
CAN008
Other Intervention Name(s)
APG101
Intervention Description
Treatment in this study is divided into four periods. Period 1 (W1-W6) is the triple therapy period in which subjects in both groups will be given CAN008 + RT + TMZ. Period 2 (W7-W10) is the treatment-free (rest) period in which subjects do not receive any study drug/therapy. Period 3 (W11-W58) is the CAN008+TMZ maintenance therapy period in which subjects in both groups are given CAN008+TMZ. Period 4 (after W59) is the monotherapy period in which subjects are given CAN008 IV infusion weekly until disease progression.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Treatment in this study is divided into four periods. Period 1 (W1-W6) is the triple therapy period in which subjects in both groups will be given placebo + RT + TMZ. Period 2 (W7-W10) is the treatment-free (rest) period in which subjects do not receive any study drug/therapy. Period 3 (W11-W58) is the placebo+TMZ maintenance therapy period in which subjects in both groups are given placebo+TMZ. Period 4 (after W59) is the monotherapy period in which subjects are given placebo IV infusion weekly until disease progression.
Primary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
To evaluate the efficacy of CAN008 plus temozolomide (TMZ) treatment in subjects with newly diagnosed glioblastoma (GBM) during and after radiation therapy
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival (OS)
Time Frame
Up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 70.
Newly diagnosed glioblastoma.
Tumor excision rate ≥80%.
Karnofsky performance score ≥70.
Exclusion Criteria:
Medical history of brain radiation therapy or electric field treatment of tumor.
Primary infratentorial glioblastoma, multifocal glioma (≥ 2), or leptomeningeal metastasis.
Any malignant tumor (excluding WHO grade I-II low-grade astrocytomas, basal cell carcinoma, and carcinoma in situ).
Receiving high-dose hormone therapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qionghui Qiu
Phone
+86 21 52996609
Ext
807
Email
qionghui.qiu@canbridgepharma.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fangmin Huang
Email
emma.huang@canbridgepharma.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wenbin Li, MD, PhD
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100070
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qionghui Qiu
Email
qionghui.qiu@canbridgepharma.com
First Name & Middle Initial & Last Name & Degree
Fangmin Huang
Email
emma.huang@canbridgepharma.com
First Name & Middle Initial & Last Name & Degree
Wenbin Li, MD, PHD
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study of CAN008 in Subjects With GBM
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