Phase 2 Study of CAN008 in Subjects With GBM
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
2 other identifiers
interventional
117
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2021
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2021
CompletedFirst Submitted
Initial submission to the registry
June 17, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedJuly 12, 2022
June 1, 2022
2.3 years
June 17, 2022
July 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Up to 3 years
Secondary Outcomes (1)
Overall survival (OS)
Up to 5 years
Study Arms (2)
CAN008
EXPERIMENTALCAN008 IV infusion weekly
placebo
PLACEBO COMPARATORPlacebo IV infusion weekly
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Age 18 to 70.
- Newly diagnosed glioblastoma.
- Tumor excision rate ≥80%.
- Karnofsky performance score ≥70.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100070, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wenbin Li, MD, PhD
Beijing Tiantan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 17, 2022
First Posted
July 7, 2022
Study Start
October 10, 2021
Primary Completion
January 31, 2024
Study Completion
August 31, 2024
Last Updated
July 12, 2022
Record last verified: 2022-06