Testing BL-M07D1 for treating certain solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: xiaosa@baili-pharm.com
• Phone: +8615013238943

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• BL-M08D in patients with digestive tract and other solid tumors

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• SI-B036 in locally advanced or metastatic breast cancer and other solid tumors

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• BL-B01D1 plus PD-1 therapy vs nab-paclitaxel plus PD-1 therapy in untreated PD-L1-positive locally advanced or metastatic TNBC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.