BridgeMD
Tests treatment safety and results for Advanced Solid Tumors
Official title Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of MB0151 in Adult Subjects With Advanced Solid Tumors Expressing Somatostatin Receptors
ClinicalTrials.gov ID: NCT06840821
What this study is testing
What is MB0151 for injection?
MB0151 for injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumors.
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 is a multicenter, open-label, single-arm, dose-escalation and dose-expansion Phase I/II study to evaluate the safety, tolerability and preliminary anti-tumor activity of MB0151 in adult subjects (at least 18 years old) with advanced solid tumors. This study includes two phases: dose escalation and dose expansion.
- 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 and older
You may be able to join if
- Male or female people over 18 years of age.
- The subject must have a solid tumor confirmed by histology or cytology, and belong to one of the following categories: 1) locally advanced or...
- ECOG PS is 0-1.
- Life expectancy ≥3 months.
- Organ function is normal, which is defined as follows: 1) Bone marrow (not treated with blood transfusion or hematopoietic stimulating factors within...
You likely can't join if
- According to the researcher's judgment, there are serious or poorly controlled systemic diseases, active bleeding tendency, renal transplantation or...
- Suffering from other malignant tumors within 3 years before the first administration, except those who have received adequate treatment: 1) Cervical...
- Meet one or more of the following cardiac criteria: 1) Severe or unstable angina pectoris; 2) Myocardial infarction, coronary artery or peripheral...
- Received major surgery within 28 days before C1D1.
- There are unstable brain metastases with clinical symptoms and/or a history of meningeal diseases, brain stem or spinal cord compression. people who...
- Have a life-threatening trauma with increased risk of bleeding or a history of severe head trauma or intracranial surgery within 2 months before...
See the full eligibility criteria
- Male or female people over 18 years of age.
- The subject must have a solid tumor confirmed by histology or cytology, and belong to one of the following categories: 1) locally advanced or metastatic SCLC, which has received standard treatment in the past and...
- ECOG PS is 0-1.
- Life expectancy ≥3 months.
- Organ function is normal, which is defined as follows: 1) Bone marrow (not treated with blood transfusion or hematopoietic stimulating factors within 14 days): absolute neutrophil (ANC) ≥ 1.5× 10 9/L, platelet count ≥...
- Detection requirements for biomarkers: 1) For the dose escalation and backfill cohort in Phase I study, biomarkers are not detected when they are selected, and the people need to provide archived or fresh tumor tissues...
- According to the RECIST version 1.1 standard, there is at least one target lesion (the target lesion must have not received radiotherapy before, or there is clear evidence of disease progression after radiotherapy).
- Male or female people who are infertile, not in pregnancy or agree to use at least one effective contraceptive method during the study intervention period (from 14 days before the first administration to at least 180...
- An informed consent form (ICF) that can be understood and signed, including compliance with ICF and the requirements and restrictions listed in this plan.
- According to the researcher's judgment, there are serious or poorly controlled systemic diseases, active bleeding tendency, renal transplantation or liver transplantation, active infection, including syphilis-specific...
- Suffering from other malignant tumors within 3 years before the first administration, except those who have received adequate treatment: 1) Cervical cancer in stage 1B or below. 2) Non-invasive basal cell or squamous...
- Meet one or more of the following cardiac criteria: 1) Severe or unstable angina pectoris; 2) Myocardial infarction, coronary artery or peripheral artery bypass grafting, stroke or transient ischemic attack and...
- Received major surgery within 28 days before C1D1.
- There are unstable brain metastases with clinical symptoms and/or a history of meningeal diseases, brain stem or spinal cord compression. people who have no clinical symptoms and have ≤3 metastatic lesions, and the...
- Have a life-threatening trauma with increased risk of bleeding or a history of severe head trauma or intracranial surgery within 2 months before enrollment.
- There is clear imaging evidence of tumor cavity or large blood vessel invasion, and the tumor is adjacent to important blood vessel structures, and the researcher judges that there is a risk of fatal bleeding.
- Peripheral motor neuropathy or peripheral neuropathy with CTCAE grade ≥2 exists.
- There are active viral, bacterial or fungal infections with clinical significance, which need the following treatment: 1) start intravenous antibacterial treatment within 4 weeks before the first administration, or 2)...
- Suffering from inflammatory bowel diseases, including Crohn's disease and ulcerative colitis.
- Pneumonia ≥ 3 or clinically significant lung diseases, such as interstitial lung disease, non-infectious pneumonia, radiation pneumonia, pulmonary fibrosis, acute lung injury, etc.; Moderate and severe asthma and...
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, 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.