Phase 2 Study of CAN008 in Subjects With GBM

Newly-diagnosed Glioblastoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05447195
• Other study ID #: CAN008-G-202
• Secondary ID: CTR20211888
• Status: Recruiting
• Phase: Phase 2
• Start date: October 10, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: June 2022
• Source: CANbridge Life Sciences Ltd.
• Contact: Qionghui Qiu
• Phone: +86 21 52996609
• Email: qionghui.qiu[@]canbridgepharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 117
• Est. completion date: August 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioblastoma
• Newly-diagnosed Glioblastoma

Intervention

Drug:
• CAN008
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.
• Placebo
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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
CANbridge Life Sciences Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall survival (OS)	Overall survival (OS)	Up to 5 years