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Trial record 1 of 1 for:    NCT05447195
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Phase 2 Study of CAN008 in Subjects With GBM

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ClinicalTrials.gov Identifier: NCT05447195
Recruitment Status : Recruiting
First Posted : July 7, 2022
Last Update Posted : July 12, 2022
Sponsor:
Information provided by (Responsible Party):
CANbridge Life Sciences Ltd.

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.

Condition or disease Intervention/treatment Phase
Newly-diagnosed Glioblastoma Drug: CAN008 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
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
Actual Study Start Date : October 10, 2021
Estimated Primary Completion Date : January 31, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CAN008
CAN008 IV infusion weekly
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.
Other Name: APG101

Placebo Comparator: placebo
Placebo IV infusion weekly
Drug: 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.




Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: Up to 3 years ]
    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 :
  1. Overall survival (OS) [ Time Frame: Up to 5 years ]
    Overall survival (OS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05447195


Contacts
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Contact: Qionghui Qiu +86 21 52996609 ext 807 qionghui.qiu@canbridgepharma.com
Contact: Fangmin Huang emma.huang@canbridgepharma.com

Locations
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China, Beijing
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100070
Contact: Qionghui Qiu       qionghui.qiu@canbridgepharma.com   
Contact: Fangmin Huang       emma.huang@canbridgepharma.com   
Principal Investigator: Wenbin Li, MD, PHD         
Sponsors and Collaborators
CANbridge Life Sciences Ltd.
Investigators
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Principal Investigator: Wenbin Li, MD, PhD Beijing Tiantan Hospital
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Responsible Party: CANbridge Life Sciences Ltd.
ClinicalTrials.gov Identifier: NCT05447195    
Other Study ID Numbers: CAN008-G-202
CTR20211888 ( Registry Identifier: Center For Drug Evaluation, NMPA, China )
First Posted: July 7, 2022    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: June 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CANbridge Life Sciences Ltd.:
Glioblastoma
CAN008
APG101
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue