Trials / Recruiting
RecruitingNCT06773481
BC008-1A Injection for Recurrent CNS WHO G4 Glioma
A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of BC008-1A Injection in Subjects With Recurrent CNS WHO Grade 4 Glioma.
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this Phase I clinical study is to evaluate the safety, preliminary efficacy and pharmacokinetic characteristics of BC008-1A injection in subjects with recurrent CNS WHO grade 4 glioma. This is a randomized and open-label study, with two dose groups set up, and 10 to 20 subjects will be enrolled in each group.
Detailed description
BC008-1A is an innovative bispecific antibody targeting TIGIT and PD-1, which is developed by Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. . BC008-1A targets PD-1 and TIGIT to block the relevant signaling pathways, relieve the inhibition on T lymphocytes, thereby facilitating the activation of T cells and achieving the functions of immune surveillance, recognition and killing of tumor cells. Subjects with recurrent CNS WHO grade 4 glioma will be randomly assigned to dose group A (900 mg) or B (1200 mg) at a ratio of 1:1. BC008-1A will be administered once every 3 weeks until disease progression, intolerable toxicity, withdrawal of informed consent, loss to follow-up, initiation of new anti-tumor treatment, the decision of the investigator for the subject to withdraw based on the subject's benefit situation, death or other circumstances, whichever occurs first.
Conditions
- Glioma
- Glioma Tumor Recurrence
- Glioma, Recurrent High Grade
- Glioblastomas (GBM)
- Glioblastoma WHO Grade IV
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BC008-1A | Biological: 900 mg BC008-1A will be intravenously injected once every 3 weeks. |
| BIOLOGICAL | BC008-1A | Biological: 1200 mg BC008-1A will be intravenously injected once every 3 weeks. |
Timeline
- Start date
- 2025-04-07
- Primary completion
- 2026-06-01
- Completion
- 2026-12-01
- First posted
- 2025-01-14
- Last updated
- 2025-07-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06773481. Inclusion in this directory is not an endorsement.