A Study of BL-ARC002 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors

The study consists of two phases: a dose-escalation phase (Phase Ia) and an expansion cohort phase (Phase Ib).

Inclusion criteria

• Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
• No gender restriction;
• Age: ≥18 and ≤75 years (Phase Ia); ≥18 years (Phase Ib);
• Expected survival ≥3 months;
• Locally advanced or metastatic esophageal squamous cell carcinoma, gastric cancer, colorectal cancer, or other solid tumors;
• Agree to provide archived tumor tissue specimens or fresh tissue samples from primary or metastatic lesions obtained within 2 years;
• Must have at least one measurable lesion as defined by RECIST v1.1;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥50%;
• Organ function levels must meet the protocol-specified requirements;
• Coagulation function: International Normalized Ratio (INR) ≤1.5, and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN);
• Urine protein ≤2+ or ≤1000 mg/24h;
• For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days prior to the start of treatment, with a negative serum pregnancy test result, and they must be non-lactating; all study participants (both male and female) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the completion of treatment.

Exclusion criteria

• Use of chemotherapy, biotherapy, immunotherapy, or other anti-tumor therapies within 4 weeks or 5 half-lives prior to the first dose;
• History of severe cardiac disease;
• QT interval prolongation, complete left bundle branch block, or third-degree atrioventricular block;
• Active autoimmune diseases and inflammatory diseases;
• Diagnosis of another malignant tumor within 5 years prior to the first dose;
• Hypertension inadequately controlled by two antihypertensive agents;
• History of interstitial lung disease (ILD) requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of Grade ≥2;
• Active central nervous system (CNS) metastases;
• Subjects with a history of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-ARC002;
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
• Cumulative anthracycline dose > 360 mg/m² from prior (neo)adjuvant anthracycline-based therapy;
• Positive for human immunodeficiency virus (HIV) antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• Active infection requiring systemic therapy;
• Participation in another clinical trial within 4 weeks prior to the first dose;
• Pregnant or breastfeeding women;
• Subjects with claustrophobia or inability to lie flat for the duration of required examinations due to various reasons;
• Any other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical trial.