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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors
ClinicalTrials.gov ID: NCT06006169
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 head and neck squamous cell carcinoma.
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 designed to investigate the efficacy and safety of BL-B01D1 monotherapy, SI-B003 monotherapy, and BL-B01D1+SI-B003 combination therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma and other solid tumors.
- 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
- All people voluntarily participated in the study and signed informed consent.
- Male or female aged ≥18 years and ≤75 years.
- Expected survival time ≥3 months.
- ECOG 0-1.
- Patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) confirmed by histopathology and/or...
You likely can't join if
- after the evaluation of the investigator.
- Must have at least one measurable lesion according to RECIST v1.1 definition; Lesions that had been previously treated with radiation could be...
- No blood transfusions and no use of cell growth factors and/or platelet-raising drugs during the 14 days prior to the screening period must be...
- Blood routine: hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥ 1.5×10 9 /L; Platelet count (PLT) ≥ 100×10 9 /L;
- Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula).
- Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≤2.5 ULN, and AST and...
See the full eligibility criteria
Who can join
- All people voluntarily participated in the study and signed informed consent.
- Male or female aged ≥18 years and ≤75 years.
- Expected survival time ≥3 months.
- ECOG 0-1.
- Patients with recurrent or metastatic head and neck squamous cell carcinoma (non-nasopharyngeal carcinoma) confirmed by histopathology and/or cytology:
- Cohort\_A, B, and Cohort\_C Stage I patients who had failed or were intolerant to 1 or more lines of systemic therapy for recurrent or metastatic HNSCC (non-nasopharyngeal carcinoma);
- Cohort\_C Stage II patients who had not received any previous systemic antitumor therapy (other than induction chemotherapy, neoadjuvant, or adjuvant therapy) for recurrent or metastatic HNSCC (non-nasopharyngeal)...
- Consent to provide archival tumor tissue specimens (10-12 unstained sections (anti-slip) surgical specimens (thickness 4-5μm)) or fresh tissue samples from primary or metastatic lesions within 3 years. If participants...
What rules you out
- after the evaluation of the investigator.
- Must have at least one measurable lesion according to RECIST v1.1 definition; Lesions that had been previously treated with radiation could be included in a measurable lesion only if there was definite disease...
- No blood transfusions and no use of cell growth factors and/or platelet-raising drugs during the 14 days prior to the screening period must be allowed, and the organ function level must meet the following criteria:
- Blood routine: hemoglobin (HGB) ≥ 90g/L; Absolute neutrophil count (NEUT) ≥ 1.5×10 9 /L; Platelet count (PLT) ≥ 100×10 9 /L;
- Renal function: creatinine (Cr) ≤1.5 ULN, or creatinine clearance (Ccr) ≥50 mL/min (according to Cockcroft and Gault formula).
- Liver function: total bilirubin (TBIL≤1.5 ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were all ≤2.5 ULN, and AST and ALT were both ≤5.0 ULN when liver metastasis was present;
- coagulation function: international normalized ratio (INR) ≤1.5 and activated partial thromboplastin time (APTT) ≤1.5ULN;
- no severe cardiac dysfunction with left ventricular ejection fraction ≥50%;
- proteinuria ≤2+ or ≤1000mg/24h.
- Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities such as ALP elevation, hyperuricemia, and hyperglycemia, as judged by...
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, the serum or urine pregnancy test must be negative, and the patient must not be...
- Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin.
- Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or targeted therapy (including small-molecule tyrosine kinase inhibitors)...
- Non-squamous cell tissue confirmed by histopathology and/or cytology must be excluded.
- Cohort\_C Stage II patients who had received any previous systemic therapy for recurrent or metastatic HNSCC (other than induction chemotherapy, adjuvant or neoadjuvant therapy) were excluded.
- Cohort\_C with a history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis, excluded.
- Cohort\_C cohort\_c who had received immunomodulatory drugs (including but not limited to thymosin, interleukin-2, interferon, etc.) within 14 days before the first dose of study drug was excluded.
- Systemic corticosteroids (\> 10mg/ day of prednisone, or the equivalent of another corticosteroid) are required within 2 weeks before the first dose of the study dose; Exceptions were inhaled or topical corticosteroids...
- A history of immunotherapy with grade ≥3 irAE or grade ≥2 immune-related myocarditis must be excluded.
- A history of severe cardiovascular and cerebrovascular diseases, including but not limited to:
- severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias or Ⅲ degree atrioventricular block requiring clinical intervention;
- prolonged QT interval at rest (QTc \> 450 msec in men or QTc \> 470 msec in women);
- myocardial infarction, unstable angina, cardiac angioplasty or stent implantation, coronary artery/peripheral artery bypass grafting, New York Heart Association (NYHA) class III or IV congestive heart failure...
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory intestinal diseases and Hashimoto's thyroiditis...
- Other malignant tumors that have progressed or require treatment within 3 years before the first dose, except for radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder...
- A history of (non-infectious) interstitial lung disease (ILD)/pulmonary inflammation requiring steroid treatment, or current ILD/ pulmonary inflammation, or suspected ILD/ pulmonary inflammation that cannot be ruled out...
- Before starting the study treatment, there are:
- Poorly controlled diabetes (fasting blood glucose ≥ 13.3 mmol/L)
- Poorly controlled hypertension (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg)
- History of hypertensive crisis or hypertensive encephalopathy.
- Unstable deep vein thrombosis, arterial thrombosis, and pulmonary embolism requiring medical intervention within 6 months before screening; Infusion-related thrombosis was excluded.
- Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases). Patients who had received treatment for brain metastases (radiotherapy or surgery; Patients with stable brain...
- Patients with pleural effusion, pericardial effusion or ascites with clinical symptoms or requiring repeated drainage.
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any excipients of BL-B01D1.
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
- Human immunodeficiency virus antibody (HIVAb) positive, active tuberculosis, active hepatitis B virus infection (HBV-DNA copy number \> 103 IU/ml) or active hepatitis C virus infection (HCV antibody positive and HCV-RNA...
- Active infections requiring systemic therapy, such as severe pneumonia, bacteremia, sepsis, etc.
- Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose).
- Persons with a history of psychotropic drug abuse and inability to quit or mental disorders.
- 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.