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New treatment option for Triple-negative Breast Cancer
Official title A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer
ClinicalTrials.gov ID: NCT06471205
What this study is testing
What is BL-B01D1?
BL-B01D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple-negative breast cancer.
Also referred to as iza-bren, izalontamab brengitecan.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Voluntarily sign the informed consent and follow the requirements of the protocol;
- Age: ≥18 years old and ≤75 years old;
- Expected survival time ≥3 months;
- ECOG 0 or 1;
- people with histologically and/or cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer;
You likely can't join if
- ADC drugs that have received topoisomerase I inhibitors as small molecule toxins;
- Palliative radiotherapy within 2 weeks before the first dose;
- Patients with checkpoint inhibitors prior to neoadjuvant/adjuvant chemotherapy;
- Use of an immunomodulatory drug within 14 days before the first dose of study drug;
- The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
See the full eligibility criteria
- Voluntarily sign the informed consent and follow the requirements of the protocol;
- Age: ≥18 years old and ≤75 years old;
- Expected survival time ≥3 months;
- ECOG 0 or 1;
- people with histologically and/or cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer;
- Patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer;
- A archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided;
- Must have at least one place in accordance with RECIST v1.1 define measurable lesions;
- No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements;
- Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be...
- ADC drugs that have received topoisomerase I inhibitors as small molecule toxins;
- Palliative radiotherapy within 2 weeks before the first dose;
- Patients with checkpoint inhibitors prior to neoadjuvant/adjuvant chemotherapy;
- Use of an immunomodulatory drug within 14 days before the first dose of study drug;
- The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Active autoimmune and inflammatory diseases;
- Receiving long-term systemic corticosteroid therapy, etc., before the first dose;
- Other malignant tumors that progressed or required treatment within 5 years before the first dose;
- Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly...
- Present grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition; Patients with current ILD;
- Complicated with pulmonary diseases leading to clinically severe respiratory impairment;
- 6 months prior to screening needs treatment intervention unstable thrombotic events;
- Patients with active central nervous system metastases;
- Patients with massive or symptomatic effusions or poorly controlled effusions;
- Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
- Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks;
- Participated in another clinical trial within 4 weeks before the first dose;
- Patients with superior vena cava syndrome should not be rehydrated;
- Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness;
- Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels;
- Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
- Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- people who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;
- Other circumstances considered by the investigator to be inappropriate for participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.