A Study of BL-M08D in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07841925, who can take part
Where in China
- Beijing Cancer HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sichuan Baili Pharmaceutical Co., Ltd.
- Trial code
- NCT07841925
- Record updated
- 29 October 2026
- Original description
This Phase Ib/II study is a clinical study to explore the efficacy and safety of BL-M08D1 for injection in patients with locally advanced or metastatic melanoma and other solid tumors.Read full original descriptionShow less
A Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Locally Advanced or Metastatic Melanoma and Other Solid Tumors
This Phase Ib/II study is a clinical study to explore the efficacy and safety of BL-M08D1 for injection in patients with locally advanced or metastatic melanoma and other solid tumors.
Inclusion: Voluntarily sign the informed consent form and comply with protocol requirements; No restriction on gender; Age: ≥18 years and ≤75 years; Expected survival time ≥3 months; Locally advanced or metastatic melanoma and other solid tumors; Agree to provide archived tumor tissue specimens from the primary or metastatic lesion within 3 years or fresh tissue samples; Must have at least one measurable lesion as defined by RECIST v1.1; ECOG performance status score of 0 or 1, with no deterioration within 2 weeks before the first dose; Toxicity from prior antitumor therapy has recovered to ≤Grade 1 as defined by NCI-CTCAE v6.0; No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; Organ function levels must meet the requirements; Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5 ULN; Urine protein ≤1+ or ≤1000 mg/24 h; For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and they must be non-lactating; all enrolled patients (whether male or female) should use adequate barrier contraception throughout the entire treatment period and for 6 months after treatment ends; Trial participants are able and willing to comply with the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol.
Exclusion: Use of chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose; Unstable thrombotic events requiring therapeutic intervention within 6 months before the first dose; Previous or concomitant central nervous system lesions; Previous organ transplantation or allogeneic hematopoietic stem cell transplantation; Presence of active infection requiring systemic treatment within 4 weeks before the first study drug administration; Presence of pleural, abdominal, pelvic effusion or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks before the first study drug administration; Use of another clinical trial drug within 4 weeks or 5 half-lives before the first dose; History of severe heart disease or cerebrovascular disease; Active autoimmune diseases and inflammatory diseases; Diagnosis of other malignancies within 5 years before the first dose; Hypertension poorly controlled by antihypertensive drugs; History of interstitial lung disease requiring hormone therapy, or current ILD or grade >= 2 radiation pneumonitis; Severe impairment of respiratory function; Patients with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient of BL-M08D1; Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection; QTc interval prolongation, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmias; Patients with poorly controlled blood glucose; Active central nervous system metastasis; Imaging examination suggesting that the tumor has invaded or encased the abdomen, chest, neck, etc; Pregnant or breastfeeding women; Other circumstances in which the investigator considers the patient unsuitable for participation in this clinical trial.