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GliomaPhase 1NCT06773481

BC008-1A Injection for Recurrent CNS WHO G4 Glioma

A Phase 1 study testing BC008-1A in people with Glioma and Glioma Tumor Recurrence, run by Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
BC008-1A
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
7 Apr 2025to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent form;
  • Recurrent CNS WHO grade 4 glioma: Subjects with CNS WHO grade 4 glioma confirmed by histopathology, who have experienced disease progression as diagnosed by MRI and evaluated by RANO criteria after standard treatment and have no surgical plan;
  • Male or female aged ≥ 18 years old;
  • Expected survival time ≥ 12 weeks;
  • According to the RANO criteria, there is at least one measurable intracranial tumor lesion;
  • KPS ≥ 70;
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  • Have sufficient hematological function, liver function and renal function, and meet the following laboratory test results before enrollment (withoutusing any cell growth factors, platelet and red blood cell transfusion or other blood transfusion treatments within 1 week before the first dose of study treatment):
  • Basically normal liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN (patients with known Gilbert disease with serum bilirubin level ≤3 × ULN can be included), alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN;
  • Basically normal renal function: Creatinine (Cr) ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min;
  • Basically normal coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for subjects receiving anticoagulant treatment, the investigator judges that INR, PT and APTT are within the safe and effective treatment range and there is no clinical condition of active bleeding or increased bleeding risk);
  • Basically normal hematological system: Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L (without granulocyte colony-stimulating factor treatment), platelet (PLT) ≥ 100 × 10^9/L, hemoglobin (Hb) ≥ 90 g/L, white blood cell count ≥ 2.0 × 10^9/L, lymphocyte count ≥ 0.5 ×10^9/L.
  • Female subjects of childbearing age or male subjects whose partners are women of childbearing age need to agree to take effective contraceptive measures during the trial period (from signing the ICF to 6 months after the last dose).

Who cannot join

  • Having been previously exposed to any anti-TIGIT, PD-1, PD-L1 or CTLA-4 drugs;
  • Having suffered from other malignant tumors and currently requiring treatment (except for cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin that have been adequately treated);
  • Having an autoimmune disease or a history of autoimmune diseases or related symptoms;
  • Subjects who cannot undergo MRI (such as those with a pacemaker implanted, non-removable metal dentures, claustrophobia, etc.);
  • Subjects who have received chemotherapy (those who have used nitrosourea drugs within 42 days before the first receipt of the experimental drug cannot be enrolled), radiotherapy, biotherapy, endocrine therapy, targeted therapy, tumor-treating fields therapy, immunotherapy or other anti-tumor treatments such as anti-tumor Chinese patent medicines within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter), or subjects who have received any clinical study treatment and the interval from the first use of the study drug is ≤ 28 days;
  • Subjects with tumor lesions involving the brainstem, spinal cord or leptomeningeal dissemination and metastasis;
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  • Those who have used corticosteroids within 1 month before participating in the trial and have received systemic treatment with a daily dose higher than 3 mg of dexamethasone or an equivalent dose of other hormones;
  • The toxicity caused by previous anti-tumor treatments has not decreased to ≤ grade 1 as defined in CTCAE version 5.0 (except for toxicities judged by the investigator to have no safety risks, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.);
  • Those who have received live attenuated vaccines within 4 weeks before the first administration of the study drug or plan to receive them during the study period;
  • Subjects with active infections at present (such as acute bacterial infections, tuberculosis, pulmonary infections, etc.);
  • Those who are positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), and whose HBV DNA is higher than the upper limit of the normal value of the site, or those judged by doctors to have active hepatitis, hepatitis C virus (HCV) infection, or those who are positive for human immunodeficiency virus (HIV) antibody, or those who are positive for Treponema pallidum antibody (Tp-Ab);
  • Those with cardiac clinical symptoms or diseases that are not well controlled, such as uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), unstable angina pectoris or myocardial infarction occurring within 6 months before enrollment in the trial, or poorly controlled arrhythmias (including QTc interval ≥ 450 ms for men and ≥ 470 ms for women, with the QTc interval calculated by the Fridericia formula), etc.;
  • Cardiac function classified as grade III or IV according to the New York Heart Association (NYHA) classification;
  • Those who are allergic to the components or excipients of the experimental drug, antibody drugs or any other therapeutic proteins (such as fresh frozen plasma, human serum albumin, cytokines or interleukins, etc.), or those with a history of severe allergies and suspected to have severe allergic reactions (NCI-CTCAEv5.0 ≥ grade 3);
  • Those with a clear history of neurological or mental disorders in the past, such as dementia, and with poor compliance;
  • Those with epilepsy and/or increased intracranial pressure that are difficult to control by drugs;
  • Pregnant or lactating women;
  • Other situations that the investigator deems unsuitable for participating in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jianing Wang contact

86-13802107048

wangjianing@buchangbio.com

Xinlei Guo contact

0086-10-87163362

guoxinlei@buchangbio.com

China1 site, 1 recruiting

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality

    Di Wang, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

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.

Read the 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.

Being tested
BC008-1A
Keywords
glioma, PD-1, TIGIT, bispecific antibody, glioblastoma
Medical subject headings
Glioma, Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BC008-1ABiological

    Biological: 900 mg BC008-1A will be intravenously injected once every 3 weeks.

  • BC008-1ABiological

    Biological: 1200 mg BC008-1A will be intravenously injected once every 3 weeks.

Study groups in NCT06773481
Study groupRoleWhat they receive
BC008-1A 900mgExperimentalNot described
Receives: Biological: BC008-1A
BC008-1A 1200mgExperimentalNot described
Receives: Biological: BC008-1A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

    Assesing the type, frequency, severity, and duration of adverse events.

    Measured: Up to 2 years

Secondary outcomes (11)

  1. objective response rate (ORR)

    Defined as the proportion of patients who have a complete response (CR) or a partial response (PR) per RANO.

    Measured: Up to 2 years

  2. Maximum Plasma Concentration (Cmax)

    Measured: 3 months

  3. Immunogenicity

    The number and incidence of subjects with anti-drug antibodies (ADA).

    Measured: Up to 2 years

  4. Karnofsky performance score(KPS)

    To evaluate the change of KPS from baseline.

    Measured: Up to 2 years

  5. Recommended phase II dose

    To determine the recommended dose for the Phase II clinical study based on the results of safety, preliminary efficacy and pharmacokinetics

    Measured: Up to 2 years

  6. Progression-free survival(PFS)

    The time interval from the first drug administration to progression per RANO or death from any cause

    Measured: Up to 2 years

  7. Overall survival (OS)

    The time interval from the first drug administration to death due to any cause.

    Measured: Up to 2 years

  8. Duration of overall response (DoR)

    the time interval from the first discovery of response (CR or PR) to progression per RANO or death from any cause

    Measured: Up to 2 years

  9. Disease control rate (DCR)

    Defined as the proportion of subjects who achieved a best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RANO.

    Measured: Up to 2 years

  10. Time to response (TTR)

    The time from the first drug administration to the first confirmation of Complete Response (CR) or Partial Response (PR) per RANO.

    Measured: Up to 2 years

  11. Area under the curve (AUC)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study start7 Apr 2025
  3. Primary completionJun 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06773481
Sponsor's protocol ID
BC0081A-103
Status last verified
Jul 2025
First submitted
2 Jan 2025
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BC008-1A in people with Glioma and Glioma Tumor Recurrence, run by Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jianing Wang (86-13802107048, wangjianing@buchangbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06773481.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.

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