A Phase II Clinical Study to Evaluate the Efficacy and Safety of SI-B003 Monotherapy and BL-B01D1+SI-B003 Combination Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors
Phase II: To explore the efficacy, safety and tolerability of BL-B01D1+SI-B003 in patients with locally advanced or metastatic non-small cell lung cancer and nasopharyngeal carcinoma, and to further explore the optimal dose and mode of combination.
• Sign the informed consent form voluntarily and follow the protocol requirements;
• Gender is not limited;
• Age: ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• Patients with histologically and/or cytologically confirmed locally advanced or metastatic solid tumors such as non-small cell lung cancer and nasopharyngeal carcinoma;
• Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 2 years;
• At least one measurable lesion meeting the RECIST v1.1 definition was required;
• ECOG 0 or 1;
• The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
⁃ No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
⁃ No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before the first use of the study drug, and the level of organ function must meet the requirements;
⁃ Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time≤1.5 ULN;
⁃ Urinary protein ≤2+ or ≤1000mg/24h;
⁃ For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum or urine must be negative for pregnancy, and must be non-lactating; All enrolled patients (male or female) were advised to use adequate barrier contraception throughout the treatment cycle and for 6 months after the end of treatment.