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New treatment option for Urothelial Carcinoma
Official title A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Urothelial Carcinoma and Other Solid Tumors
ClinicalTrials.gov ID: NCT05965856
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 urothelial 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 explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with locally advanced or metastatic urothelial 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;
- Locally advanced or metastatic urothelial carcinoma and other solid tumors confirmed by histopathology and/or cytology who have failed or cannot...
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...
- Provided that no blood transfusions and no use of any cell growth factors and/or platelet-raising agents are allowed for 14 days prior to the...
- 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) ≥40 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;
- Locally advanced or metastatic urothelial carcinoma and other solid tumors confirmed by histopathology and/or cytology who have failed or cannot tolerate standard treatment or who currently have no standard treatment or...
- Consent to provide archival tumor tissue specimens (10 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...
- Provided that no blood transfusions and no use of any cell growth factors and/or platelet-raising agents are allowed for 14 days prior to the screening period, organ function levels 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) ≥40 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%;
- Toxicity from previous antineoplastic therapy has returned to grade 1 or less as defined by NCI-CTCAE v5.0 (asymptomatic laboratory abnormalities such as ALP elevation, hyperuricemia, and hyperglycemia were considered...
- 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...
- Previous use of an ADC drug with a topoisomerase I inhibitor as a toxin;
- Administration of chemotherapy or chemotherapy within 4 weeks or 5 half-lives, whichever is shorter, before the first dose Physical therapy, immunotherapy, definitive radiotherapy, major surgery (investigator's...
- Patients with a history of immunotherapy and grade ≥3 irAE or grade ≥2 immune-related myocarditis must be excluded;
- Use of immunomodulatory drugs within 14 days before the first use of the study drug, including but not limited to thymosin, Interleukin-2, interferon, etc. 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 grade III atria requiring clinical intervention Ventricular block;
- prolonged QT interval at rest (QTc \> 450 msec in men or QTc \> 470 msec in women);
- cerebrovascular accident or transient ischemic attack within 6 months before the first dose; Symptomatic congestive History of heart failure (CHF) ≥ grade 2 (CTCAE 5.0) and New York Heart Association (NYHA) ≥ Grade 2...
- Active autoimmune diseases and inflammatory diseases, such as systemic lupus erythematosus, requiring systemic treatment Psoriasis, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc...
- Systemic corticosteroids (\> 10mg/ day prednisone, or equivalent) are required within 2 weeks before the study dose Doses of other corticosteroids) or immunosuppressive agents; Inhaled or topical administration of...
- Other malignancies that progressed or required treatment within 5 years before the first dose, such as the following External: radical resection of skin basal cell carcinoma, skin squamous cell carcinoma, superficial...
- History of (noninfectious) interstitial lung disease (ILD)/pulmonary inflammation requiring steroid therapy, or when Patients with previous ILD/ pulmonary inflammation, or suspected ILD/ pulmonary inflammation that...
- Prior to 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 Thrombotic events such as plug; Infusion-related thrombosis was excluded.
- Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases). But he had a brain turn Metastatic therapy (radiotherapy or surgery; And the people had stopped radiotherapy...
- Patients with large amount of serous cavity effusion, or serous cavity effusion with symptoms, or before signing informed consent Patients who underwent drainage within 4 weeks;
- Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or to BL-B01D1, SI-B003 Patients who are allergic to excipients;
- 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 (anti-HCV Body positive and...
- Active infection requiring systemic treatment, such as severe pneumonia, bacteremia, sepsis, etc.
- Participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);
- Persons who have a history of psychotropic drug abuse and cannot be abstinent or have mental disorders;
- Any other circumstances that the investigator deemed 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.