Evaluating BL-M08D1 for advanced solid tumors

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M08D1 for Injection in Patients With Locally Advanced or Metastatic Solid Tumors

This study is testing a new treatment called BL-M08D1 to see if it is safe and effective for people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Chemotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06718621 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter phase I clinical study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-M08D1 in patients with locally advanced or metastatic solid tumors. The study will involve dose-escalation and expansion enrollment to determine the optimal dosage and monitor patient responses. Participants will be required to provide tumor tissue samples and have measurable lesions as defined by RECIST criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced or metastatic solid tumors that are incurable or have no standard treatment options.

Not a fit: Patients with solid tumors that are amenable to standard treatments or those with severe cardiac dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced solid tumors that currently lack effective standard treatments.

How similar studies have performed: While this approach is part of ongoing research in cancer treatment, the specific use of BL-M08D1 in this context is novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

1. Sign the informed consent form voluntarily and follow the protocol requirements;
2. Gender is not limited;
3. Age: ≥18 years old and ≤75 years old (phase Ia); ≥18 years old (phase Ib);
4. Expected survival time ≥3 months;
5. Locally advanced or metastatic solid tumors confirmed by histopathology and/or cytology that are incurable or currently have no standard treatment;
6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. ECOG 0 or 1;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. 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;
12. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
13. Urinary protein ≤2+ or ≤1000mg/24h;
14. 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 patients (regardless of male or female) should use adequate barrier contraception during the whole treatment cycle and for 6 months after the end of treatment;
15. Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.

Exclusion Criteria:

1. 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; Oral drugs such as fluorouracil;
2. History of severe heart disease;
3. QT prolongation, complete left bundle branch block, III degree atrioventricular block;
4. Active autoimmune and inflammatory diseases;
5. Other malignant tumors diagnosed within 5 years before the first dose;
6. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
7. History of ILD requiring steroid therapy or current ILD or ≥ grade 2 radiation pneumonitis;
8. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
9. Had symptoms of active central nervous system metastasis;
10. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of the ingredients of BL-M08D1;
11. Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
12. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
13. Active infection requiring systemic therapy within 4 weeks before the first dose of study drug;
14. Pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or with symptoms within 4 weeks before the first dose of study drug;
15. Received another trial drug 4 weeks or 5 half-lives before the first dose;
16. Pregnant or lactating women;
17. The investigator did not consider it appropriate to apply other criteria for participation in the trial.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Sa Xiao, PHD

Conditions Solid Tumor