Trial record 1 of 1 for:
NCT05447195
Phase 2 Study of CAN008 in Subjects With GBM
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05447195 |
|
Recruitment Status :
Recruiting
First Posted : July 7, 2022
Last Update Posted : July 12, 2022
|
Sponsor:
CANbridge Life Sciences Ltd.
Information provided by (Responsible Party):
CANbridge Life Sciences Ltd.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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 :
- 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 :
- Overall survival (OS) [ Time Frame: Up to 5 years ]Overall survival (OS)
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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
| Contact: Qionghui Qiu | +86 21 52996609 ext 807 | qionghui.qiu@canbridgepharma.com | |
| Contact: Fangmin Huang | emma.huang@canbridgepharma.com |
Locations
| 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
| Principal Investigator: | Wenbin Li, MD, PhD | Beijing Tiantan Hospital |
| 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 |
| 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:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |