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New treatment option for Gastrointestinal Tumor
Official title A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor
ClinicalTrials.gov ID: NCT05262491
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 gastrointestinal 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 gastrointestinal tumor and other 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 (phase Ia); ≥18 years old (phase Ib).
- Expected survival time ≥ 3 months.
- Patients with locally advanced or metastatic triple-negative breast cancer or other solid tumors who have been diagnosed histopathologically and/or...
You likely can't join if
- Patients screened for any of the following conditions will not be included in this study:
- Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of...
- Prior treatment with ADC drugs targeting TROP2 or ADC drugs using camptothecin derivatives (topoisomerase I inhibitors) as toxins.
- 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...
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 (phase Ia); ≥18 years old (phase Ib).
- Expected survival time ≥ 3 months.
- Patients with locally advanced or metastatic triple-negative breast cancer or other solid tumors who have been diagnosed histopathologically and/or cytologically as failing standard therapy, or who are not eligible for...
- Agree to provide archived tumor tissue samples or fresh tissue samples from the primary tumor or metastatic tumor within 3 years (TROP2 protein expression in tumor pathological tissue to explore the correlation between...
- Participants must have at least one assessable lesion as defined by RECIST V1.1.
- Has an Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1
- The toxicity of previous antitumor therapy was restored to ≤1 as defined by NCI-CTCAE v5.0 (except for asymptomatic laboratory abnormalities considered by the investigators, such as elevated ALP, hyperuricemia, and...
- Has adequate organ function before registration, defined as: a) Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×109/L, Platelet count ≥90×109/L, Hemoglobin ≥90 g/L; B) Hepatic function: Total bilirubin...
- Coagulation function: International normalized ratio (INR)≤1.5, 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. Adequate barrier...
- Patients screened for any of the following conditions will not be included in this study:
- 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...
- Prior treatment with ADC drugs targeting TROP2 or ADC drugs using camptothecin derivatives (topoisomerase I inhibitors) as toxins.
- 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...
- The presence of a second primary tumor within 5 years prior to initial administration, except for radical basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or radical resected carcinoma in situ.
- Screening for unstable thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism requiring therapeutic intervention within the first 6 months; Infusion device-related thrombosis is...
- 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 \> 103IU/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
- Beijing, Beijing Municipality, China
- Nanchang, Jiangxi, China
- Jinan, Shandong, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Beijing, Beijing Municipality, China; Nanchang, Jiangxi, China; Jinan, Shandong, China; Chengdu, Sichuan, China; Tianjin, Tianjin Municipality, China; Hangzhou, Zhejiang, 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.