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New treatment option for Solid Tumor
Official title A Study of BL-M08D1 in Patients With Locally Advanced or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT06718621
What this study is testing
What is BL-M08D1?
BL-M08D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
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 an open, multicenter, dose-escalation and expansion-enrollment, nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of BL-M08D1 for injection in locally advanced or metastatic solid tumors.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Gender is not limited;
- Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);
- Expected survival time ≥3 months;
- Locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology that are incurable or currently have no standard treatment;
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...
- History of severe heart disease;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block;
- Active autoimmune and inflammatory diseases;
- Other malignant tumors diagnosed within 5 years before the first dose;
- Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
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 (phase Ia); ≥18 years old (phase Ib);
- Expected survival time ≥3 months;
- Locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology that are incurable or currently have no standard treatment;
- Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
- At least one measurable lesion meeting the RECIST v1.1 definition was required;
- ECOG 0 or 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%;
- No blood transfusion, no use of cell growth factors and/or platelet-raising drugs within 14 days before screening, and the organ function level must meet the requirements;
- 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 performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled...
- people were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.
- 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...
- History of severe heart disease;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block;
- Active autoimmune and inflammatory diseases;
- Other malignant tumors diagnosed within 5 years before the first dose;
- Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
- History of ILD requiring steroid therapy or current ILD or ≥ grade 2 radiation pneumonitis;
- Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
- Had symptoms of active central nervous system metastasis;
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M08D1;
- Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
- Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
- Active infection requiring systemic therapy within 4 weeks before the first dose of study drug;
- Pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or with symptoms within 4 weeks before the first dose of study drug;
- Received another trial drug 4 weeks or 5 half-lives before the first dose;
- Pregnant or lactating women;
- The investigator did not consider it appropriate to apply other criteria for participation in the trial.
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 and older. 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.