Testing BL-M07D1 for treating certain solid tumors

A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of BL-M07D1 for Injection in Patients With Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Solid Tumors

This study is testing a new treatment called BL-M07D1 to see if it can safely help people with certain types of advanced solid tumors, especially those related to the urinary and gastrointestinal systems.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06031584 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of BL-M07D1 in patients with various solid tumors, particularly focusing on locally advanced or metastatic HER2-positive/low-expressing urinary and gastrointestinal tumors. The trial consists of two phases: Phase Ib aims to determine the recommended phase 2 dose (RP2D), while Phase II assesses the efficacy of the treatment. Patients will be monitored for their response to the drug and any adverse effects experienced during the treatment.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with unresectable, locally advanced or metastatic HER2-positive/low-expressing urinary and gastrointestinal tumors that have not responded to standard therapies.

Not a fit: Patients with tumors that are resectable or those who have not yet undergone standard therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat solid tumors.

How similar studies have performed: While this approach is being explored in this specific context, similar studies targeting HER2-positive tumors have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. No gender restrictions;
3. Age: ≥18 years and ≤75 years;
4. Expected survival time ≥3 months;
5. Patients with unresectable locally advanced or metastatic HER2-positive/low-expressing urological and digestive system tumors, as well as other solid tumors;
6. Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 2 years;
7. Must have at least one measurable lesion as defined by RECIST v1.1;
8. ECOG performance status score of 0 or 1;
9. Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
11. Organ function levels must meet the requirements;
12. Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
13. Urine protein ≤2+ or ≤1000 mg/24h;
14. Albumin ≥30 g/L;
15. For premenopausal women with childbearing potential, a pregnancy test (serum/urine) must be performed within 7 days before starting treatment, and the result must be negative; they must not be breastfeeding. All enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 7 months after treatment ends.

Exclusion Criteria:

1. Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose;
2. Previously treated with ADC drugs containing camptothecin derivatives as payloads;
3. History of severe cardiovascular or cerebrovascular diseases;
4. Active autoimmune or inflammatory diseases;
5. History of other malignancies within 5 years prior to the first dose;
6. Thrombotic events requiring therapeutic intervention within 6 months before screening;
7. Patients with significant pleural/peritoneal/pelvic effusion or pericardial effusion, or those with symptomatic effusion, or poorly controlled effusion;
8. Poorly controlled hypertension despite antihypertensive medication;
9. Current interstitial lung disease, drug-induced interstitial pneumonitis, radiation pneumonitis requiring steroid treatment, or history of these conditions;
10. Patients with primary central nervous system (CNS) tumors or CNS metastases that failed local treatment;
11. History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-M07D1;
12. Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
13. Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, or active hepatitis C virus (HCV) infection;
14. Active hepatitis B virus (HBV) infection (exclusion criterion);
15. Severe infection requiring systemic treatment within 4 weeks before the first dose of the study drug;
16. Participation in another clinical trial within 4 weeks before the first dose;
17. Pregnant or lactating women;
18. Any other condition deemed unsuitable for participation in this clinical trial by the investigator.

Where this trial is running

Beijing, Beijing Municipality

• Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Aiping Zhou, PHD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Sa Xiao, PHD

Conditions Her2-positive/Low-expression Urinary and Digestive Tract Tumors