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
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
Sichuan Baili Pharmaceutical Co., Ltd.
42 participants
Jan 19, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria15
- Voluntarily sign the informed consent form and comply with the protocol requirements;
- No gender restrictions;
- Age: ≥18 years and ≤75 years;
- Expected survival time ≥3 months;
- Patients with unresectable locally advanced or metastatic HER2-positive/low-expressing urological and digestive system tumors, as well as other solid tumors;
- Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions within the past 2 years;
- Must have at least one measurable lesion as defined by RECIST v1.1;
- ECOG performance status score of 0 or 1;
- Toxicity from prior anti-tumor therapy has recovered to ≤ Grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
- Organ function levels must meet the requirements;
- Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5 × ULN;
- Urine protein ≤2+ or ≤1000 mg/24h;
- Albumin ≥30 g/L;
- 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 Criteria18
- Received chemotherapy, biological therapy, immunotherapy, or other antitumor treatments within 4 weeks or 5 half-lives prior to the first dose;
- Previously treated with ADC drugs containing camptothecin derivatives as payloads;
- History of severe cardiovascular or cerebrovascular diseases;
- Active autoimmune or inflammatory diseases;
- History of other malignancies within 5 years prior to the first dose;
- Thrombotic events requiring therapeutic intervention within 6 months before screening;
- Patients with significant pleural/peritoneal/pelvic effusion or pericardial effusion, or those with symptomatic effusion, or poorly controlled effusion;
- Poorly controlled hypertension despite antihypertensive medication;
- Current interstitial lung disease, drug-induced interstitial pneumonitis, radiation pneumonitis requiring steroid treatment, or history of these conditions;
- Patients with primary central nervous system (CNS) tumors or CNS metastases that failed local treatment;
- History of hypersensitivity to recombinant humanized antibodies or human-mouse chimeric antibodies, or any excipients of BL-M07D1;
- Previous organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Positive for human immunodeficiency virus (HIV) antibodies, active tuberculosis, or active hepatitis C virus (HCV) infection;
- Active hepatitis B virus (HBV) infection (exclusion criterion);
- Severe infection requiring systemic treatment within 4 weeks before the first dose of the study drug;
- Participation in another clinical trial within 4 weeks before the first dose;
- Pregnant or lactating women;
- Any other condition deemed unsuitable for participation in this clinical trial by the investigator.
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Interventions
BL-M07D1 was administered by intravenous infusion every 3 weeks in 3-week cycles.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06031584