BridgeMD
New treatment option for Renal Cancer
Official title A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer
ClinicalTrials.gov ID: NCT06962787
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 renal 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 in combination with tyrosine kinase inhibitor (TKI) with or without pembrolizumab (BL-B01D1+TKI±Pembrolizumab) in patients with locally advanced or metastatic renal 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
- Subject volunteered to participate in the study and signed an informed consent;
- Male or female aged ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- ECOG score 0 or 1;
- Patients with locally advanced or metastatic renal cell carcinoma confirmed by histopathology and/or cytology;
You likely can't join if
- Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and...
- Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin;
- Use of immunomodulatory drugs within 14 days before the first dose of study drug;
- The history of severe cardiovascular and cerebrovascular diseases within six months before screening;
- Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Active autoimmune and inflammatory diseases;
See the full eligibility criteria
- Subject volunteered to participate in the study and signed an informed consent;
- Male or female aged ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- ECOG score 0 or 1;
- Patients with locally advanced or metastatic renal cell carcinoma confirmed by histopathology and/or cytology;
- Agree to provide archived tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
- At least one measurable lesion meeting the RECIST v1.1 definition was required;
- Organ function level must meet the requirements;
- The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- Fertile female people, or male people with fertile partners, must use highly effective contraception from 7 days before the first dose until 7 months after the first dose. Female people of childbearing potential had to...
- Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose...
- Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase I inhibitor) as a toxin;
- Use of immunomodulatory drugs within 14 days before the first dose of study drug;
- The history of severe cardiovascular and cerebrovascular diseases within six months before screening;
- Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Active autoimmune and inflammatory diseases;
- Systemic corticosteroids or immunosuppressive agents are required within 2 weeks before the first dose;
- Other malignant tumors within 5 years before the first dose;
- A history of non-infectious ILD requiring steroid treatment, or current ILD/interstitial pneumonia or suspected ILD;
- Poorly controlled diabetes before starting study treatment; Severe complications of diabetes mellitus;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
- Patients with active central nervous system metastasis;
- Patients with massive or symptomatic effusions or poorly controlled effusions;
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to BL-B01D1 or any excipients of pembrolizumab;
- Previous history of allogeneic stem cell, bone marrow or organ 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; There was pulmonary infection or active pulmonary inflammation at the time of screening;
- Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);
- With a history of psychotropic drug abuse and 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;
- people with 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;
- Patients with other serious physical and laboratory abnormalities or poor compliance that may increase the risk of participating in the study, or interfere with the results of the study, and patients who were deemed by...
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.