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Recurrent GlioblastomaPhase 2NCT06598787

A Study of BL-B01D1 in Patients With Recurrent Glioblastoma

A Phase 2 study testing BL-B01D1 for Injection in people with Recurrent Glioblastoma, run by Sichuan Baili Pharmaceutical 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

This is an open-label, multicenter, phase II study to evaluate the safety, efficacy, and pharmacokinetic characteristics of BL-B01D1 for Injection in patients with recurrent glioblastoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Glioblastoma
What is being tested?
BL-B01D1 for Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
17 Oct 2024to Oct 2026
Phase
Phase 2
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

  • Sign the informed consent form voluntarily and follow the protocol requirements;
  • Gender is not limited;
  • Age: ≥18 years old;
  • Recurrent glioblastoma confirmed by pathology after failure of standard treatment;
  • KPS≥60;
  • The expected survival time as judged by the investigator was ≥3 months;
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  • The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
  • No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
  • No blood transfusion, albumin, colony-stimulating factor, any cell growth factor and/or platelet-raising drugs are allowed within 14 days before the first dose of study drug, and the organ function level must meet the requirements;
  • Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
  • Urine protein ≤2+ or < 1000mg/24h;
  • A pregnancy test must be performed within 7 days before starting treatment for premenopausal women who are likely to have children, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Who cannot join

  • Chemotherapy, biological therapy, immunotherapy, etc., had been used within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy had been used within 5 days, palliative radiotherapy, modern Chinese medicine preparations approved by NMPA for anti-tumor treatment had been used within 2 weeks;
  • A history of central nervous system hemorrhage/infarction requiring treatment unrelated to antineoplastic drugs within 6 months before enrollment;
  • History of severe heart disease and cerebrovascular disease;
  • Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, severe arrhythmia;
  • Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
  • Active autoimmune and inflammatory diseases;
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  • Other malignant tumors that progressed or required treatment within 5 years before the first dose;
  • Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);
  • Patients with poor glycemic control or with diabetic gangrene;
  • Patients with a previous history of ILD, or current ILD or ≥G2 radiation pneumonitis, or suspected to have such disease by imaging during screening;
  • Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
  • Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B01D1;
  • Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
  • Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
  • Had a serious infection within 4 weeks before the first dose of study drug; Indications of active pulmonary infection within 2 weeks before the first dose of study drug;
  • Imaging examination indicated that the tumor had invaded or enveloped the large vessels of the chest, neck, and pharynx, except for those that the investigator thought would not affect the patient's enrollment in the drug;
  • Other circumstances that the investigator deemed inappropriate for participation in the trial.

Trial locations and contacts

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

Sa Xiao, PHD contact

15013238943

xiaosa@baili-pharm.com

China1 site, 1 recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Wenbin Li

    Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Recurrent Glioblastoma

This is an open-label, multicenter, phase II study to evaluate the safety, efficacy, and pharmacokinetic characteristics of BL-B01D1 for Injection in patients with recurrent glioblastoma.

Being tested
BL-B01D1 for Injection
Medical subject headings
Glioblastoma

What participants receive

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

  • BL-B01D1 for InjectionDrug

    Also called iza-bren, izalontamab brengitecan, BMS-986507

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT06598787
Study groupRoleWhat they receive
BL-B01D1 for InjectionExperimentalParticipants receive BL-B01D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Receives: Drug: BL-B01D1 for Injection

What is being measured

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

  1. Objective response rate (ORR)

    ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1.

    Measured: Up to approximately 24 months

Secondary outcomes (8)

  1. Progression-free survival (PFS)

    The PFS is defined as the time from the participant's first dose of BL-B01D1 to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

  2. Disease control rate (DCR)

    The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease [PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD]).

    Measured: Up to approximately 24 months

  3. Duration of response (DOR)

    The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first.

    Measured: Up to approximately 24 months

  4. Treatment-Emergent Adverse Event (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.

    Measured: Up to approximately 24 months

  5. Cmax

    Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.

    Measured: Up to approximately 24 months

  6. Tmax

    Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated.

    Measured: Up to approximately 24 months

  7. Ctrough

    Ctrough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.

    Measured: Up to approximately 24 months

  8. ADA (anti-drug antibody)

    Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted19 Sep 2024
  2. Study start17 Oct 2024
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06598787
Sponsor's protocol ID
BL-B01D1-205
Status last verified
May 2025
First submitted
12 Sep 2024
Last updated
7 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BL-B01D1 for Injection in people with Recurrent Glioblastoma, run by Sichuan Baili Pharmaceutical 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 17 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 7 May 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: Up to approximately 24 months). 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 NCT06598787.

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 7 May 2025.

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