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New treatment option for Urinary System Tumor
Official title A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors
ClinicalTrials.gov ID: NCT05785039
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 urinary system tumor.
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
- Phase IIa/IIb clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of BL-B01D1 for injection in patients with multiple solid tumors such as locally advanced or metastatic urinary system 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
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Gender is not limited;
- Age: ≥18 years old and ≤75 years old;
- Expected survival time ≥3 months;
- Locally advanced or metastatic urothelial carcinoma and other solid tumors confirmed by histopathology and/or cytology after failure or intolerance...
You likely can't join if
- At least one measurable lesion (other than prostate cancer), as defined by RECIST v1.1, was required;
- ECOG 0 or 1;
- The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- With adequate organ function;
- For premenopausal women who are likely to have children, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine...
See the full eligibility criteria
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Gender is not limited;
- Age: ≥18 years old and ≤75 years old;
- Expected survival time ≥3 months;
- Locally advanced or metastatic urothelial carcinoma and other solid tumors confirmed by histopathology and/or cytology after failure or intolerance to standard treatment or for which standard treatment is currently...
- Testosterone levels in prostate cancer \< 1.73 nmol/L (50 ng/dL), disease progression before screening, according to the PCWG3 consensus;
- Agree to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years. If the people cannot provide tumor tissue samples, they can be enrolled after the evaluation of the...
- At least one measurable lesion (other than prostate cancer), as defined by RECIST v1.1, was required;
- ECOG 0 or 1;
- The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- With adequate organ function;
- For premenopausal women who are likely to have children, a pregnancy test must be performed within 7 days before starting treatment, a serum or urine pregnancy test must be negative, and the patient must not be...
- Antineoplastic therapy within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral fluorouracil drugs;
- History of severe cardiovascular and cerebrovascular diseases;
- Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Active autoimmune and inflammatory diseases;
- Other malignant tumors that progressed or required treatment within 5 years before the first dose;
- Patients with poor blood glucose control before the first dose;
- Hypertension poorly controlled with two antihypertensive drugs before the first dose or previous history of hypertensive crisis or hypertensive encephalopathy;
- A history of interstitial lung disease (ILD), current ILD, or suspicion of such disease on imaging during screening;
- Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
- Were receiving \> before the first dose; Long-term systemic corticosteroid therapy with 10mg/ day prednisone or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- Patients with central nervous system (CNS) metastases and/or carcinomatous meningitis (meningeal metastases) and/or spinal cord compression;
- Patients with massive or symptomatic effusions or poorly controlled effusions;
- Imaging examination indicated that the tumor had invaded or wrapped the large blood vessels of the chest, neck, and pharynx, except that the investigator thought that it would not affect the patient's enrollment in the...
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B01D1's excipients;
- Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
- 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;
- Patients with superior vena cava syndrome should not be rehydrated;
- Had a history of severe neurological or psychiatric disorders;
- Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels;
- Serious unhealed wounds, ulcers, or fractures, or clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- people scheduled to receive live vaccine or within 28 days before the first dose;
- 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.