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New treatment option for Advanced Hepatocellular Carcinoma
Official title A Study of BL-B01D1 Monotherapy, BL-B01D1 in Combination With Lenvatinib, BL-B01D1 in Combination With PD-1 Monoclonal Antibody, and BL-B01D1 in Combination With PD-1 Monoclonal Antibody and Bevacizumab in Patients With Advanced Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06986785
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 advanced hepatocellular 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 study is a clinical study to explore the efficacy and safety of BL-B01D1 monotherapy, BL-B01D1 in combination with lenvatinib, BL-B01D1 in combination with PD-1 monoclonal antibody, and BL-B01D1 in combination with PD-1 monoclonal antibody and bevacizumab in patients with advanced hepatocellular carcinoma.
- 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;
- Patients with advanced HCC confirmed by histology or cytology;
You likely can't join if
- Patients with active central nervous system metastases;
- Who had participated in any other clinical trial within 4 weeks before the trial dose;
- Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug;
- Had undergone major surgery (investigator-defined) within 4 weeks before the first dose;
- Systemic corticosteroids or immunosuppressive therapy is required within 2 weeks before study dosing;
- Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD/pulmonary inflammation requiring steroid treatment;
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;
- Patients with advanced HCC confirmed by histology or cytology;
- Consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions;
- At least one measurable lesion meeting the RECIST v1.1 definition was required;
- ECOG score was 0-1;
- The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- Organ function level must meet the requirements;
- Coagulation function: international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Urinary protein ≤2+ or ≤1000mg/24h;
- No cirrhosis or only Child-Pugh A cirrhosis;
- If hepatitis B virus infection is negative or positive, the status of HBV surface antigen (HBsAg) should be confirmed by HBV serological test;
- For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before the start of treatment, a serum or urine pregnancy test must be negative, and the patient must not be lactating...
- Patients with active central nervous system metastases;
- Who had participated in any other clinical trial within 4 weeks before the trial dose;
- Received anti-tumor therapy such as chemotherapy, radiotherapy and biological therapy within 4 weeks before the first use of study drug;
- Had undergone major surgery (investigator-defined) within 4 weeks before the first dose;
- Systemic corticosteroids or immunosuppressive therapy is required within 2 weeks before study dosing;
- Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD/pulmonary inflammation requiring steroid treatment;
- Serious systemic infection within 4 weeks before screening;
- Patients at risk for active autoimmune disease or with a history of autoimmune disease;
- Other malignant tumors within 5 years before the first treatment;
- Human immunodeficiency virus antibody positive, active tuberculosis or hepatitis C virus infection;
- Poorly controlled hypertension by two antihypertensive drugs with different mechanisms;
- Diabetic patients with poor glycemic control;
- Had a history of severe cardiovascular and cerebrovascular diseases;
- Previous history of autologous or allogeneic stem cell, bone marrow or organ transplantation;
- people with clinically significant bleeding or significant bleeding tendency within the previous 4 weeks were screened;
- Patients with massive or symptomatic effusions or poorly controlled effusions;
- Imaging examination showed that the tumor had invaded or wrapped around the chest, neck, pharynx and other large arteries or invaded the pericardium and heart;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- Prior treatment with an ADC drug with a topoisomerase I inhibitor as a toxin;
- Patients with a history of allergy to recombinant humanized antibodies or to any excipients of the trial drug;
- The cumulative dose of anthracyclines \> 360 mg/m2 in previous (new) adjuvant therapy;
- Pregnant or lactating women;
- Who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
- Other conditions for trial participation were not considered appropriate by the investigator.
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.