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New treatment option for Locally Advanced or Metastatic Solid Tumor
Official title A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor
ClinicalTrials.gov ID: NCT05194982
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 locally advanced or metastatic solid 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
- In phase Ia study, the safety and tolerability of BL-B01D1 in patients with locally advanced or metastatic solid tumor will be investigated to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) of BL-B01D1. In phase Ib study, the safety and tolerability of BL-B01D1 at the phase Ia recommended dose will be further investigated, and recommended phase II dose (RP2D) for phase II clinical studies will be determined.
- Phase 1: an early, usually small safety study
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
- Participants must sign the informed consent form voluntarily and follow the plan requirements.
- No gender limit.
- Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib).
- Expected survival time ≥ 3 months.
- Locally advanced or metastatic solid tumor confirmed by histopathology and/or cytology, which are incurable or currently without standard treatment.
You likely can't join if
- Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of...
- Participants with history of severe heart disease, such as: symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE 5.0), New York Heart...
- Participants with prolonged QT interval (male QTc\> 450 msec or female QTc\> 470 msec), complete left bundle branch block, III grade atrioventricular...
- Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid...
- Other malignant tumors were diagnosed within 5 years prior to the first administration with the following exceptions: basal cell carcinoma of the...
- Participants with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure\>150 mmHg or diastolic blood...
See the full eligibility criteria
- Participants must sign the informed consent form voluntarily and follow the plan requirements.
- No gender limit.
- Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib).
- Expected survival time ≥ 3 months.
- Locally advanced or metastatic solid tumor confirmed by histopathology and/or cytology, which are incurable or currently without standard treatment.
- Agrees to provide archived tumor tissue specimens or fresh tissue samples from the primary lesion or metastasis within 2 years; If a subject is unable to provide a tumor tissue sample, he/she may be enrolled after being...
- Participants must have at least one measurable lesion that meets the definition of RECIST v1.1.
- Physical fitness score ECOG 0 or 1 point
- Toxicity of previous antitumor therapy has returned to ≤ level 1 as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities considered by the investigators, such as elevated ALP, hyperuricemia, and...
- No serious cardiac dysfunction, left ventricular ejection fraction (LVEF) ≥50%
- The organ function level must meet the following requirements: a) bone marrow function: absolute neutrophilic granulocyte count (ANC) ≥1.5×109/L, platelet count ≥90×109/L, hemoglobin ≥90 g/L; b) Liver function: total...
- Coagulation function: International normalized ratio (INR)≤1.5×ULN, and activated partial thromboplastin time (APTT)≤1.5ULN.
- Urinary protein ≤2+ or ≤1000mg/24h.
- For premenopausal women with childbearing potential, a pregnancy test must be taken within 7 days prior to the start of treatment. Serum or urine pregnancy must be negative and must be non-lactating; all participants...
- Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anti-tumor therapy within 4 weeks or 5 half-lives...
- Participants with history of severe heart disease, such as: symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE 5.0), New York Heart Association (NYHA) ≥ grade 2 heart failure, history of transmural myocardial...
- Participants with prolonged QT interval (male QTc\> 450 msec or female QTc\> 470 msec), complete left bundle branch block, III grade atrioventricular block.
- Active autoimmune diseases and inflammatory diseases, such as: systemic lupus erythematosus, psoriasis requiring systemic treatment, rheumatoid arthritis, inflammatory bowel disease and Hashimoto's thyroiditis, etc...
- Other malignant tumors were diagnosed within 5 years prior to the first administration with the following exceptions: basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or carcinoma in situ after...
- Participants with poorly controlled hypertension by two kinds of antihypertensive drugs (systolic blood pressure\>150 mmHg or diastolic blood pressure\>100 mmHg).
- Participants have grade 3 lung disease defined according to NCI-CTCAE v5.0, or a history of interstitial lung disease (ILD).
- Unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism requiring therapeutic intervention within 6 months prior to screening; Thrombus formation associated with infusion set...
- Symptoms of active central nervous system metastasis. However, patients with stable brain parenchymal metastases can be enrolled. Stable was defined as: a. The seizure-free state lasted for \> 12 weeks with or without...
- Patients with a history of allergy to recombinant humanized antibody or mouse chimeric antibody or to any excipients of BL-B01D1.
- Previous recipients of organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT).
- In previous adjuvant therapy with anthracyclines, the cumulative dose of anthracyclines was \> 360 mg/m2.
- Positive human immunodeficiency virus antibody (HIVAb), 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 treatment, such as severe pneumonia, bacteremia, septicemia, etc.
- Participated in another clinical trial (calculated from the time of the last dose) within 4 weeks prior to the first dose.
- The other conditions of participation in this clinical trial were not considered appropriate by the investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
- Wuhan, Hubei, China
- Changsha, Hunan, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, 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 Chongqing, Chongqing Municipality, China; Guangzhou, Guangdong, China; Wuhan, Hubei, China; Changsha, Hunan, China; Shanghai, Shanghai Municipality, China; Taiyuan, Shanxi, 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.