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Clinical Trials in China / NCT06031584
Recruiting Phase 1/2

A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors

NCT06031584 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Phase
Phase 1/2
Started
2024-01-19
Last updated
2026-04-08

Condition(s) studied

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

Investigational drug(s) / intervention(s)

BL-M07D1

BL-M07D1: BL-M07D1 was administered by intravenous infusion every 3 weeks in 3-week cycles.

Study summary

Phase Ib: Explore the safety and tolerability of BL-M07D1 to further define RP2D in a variety of solid tumors, including locally advanced or metastatic urinary and gastrointestinal tumors. Phase II: To explore the efficacy of BL-M07D1 in patients with a variety of solid tumors including locally advanced or metastatic HER2-positive/low-expressing urinary and gastrointestinal tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality Recruiting

More Sichuan Baili Pharmaceutical Co., Ltd. trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06031584 on ClinicalTrials.gov ↗ ← All trials in China