Clinical Research Directory

Inclusion Criteria: * Willing to sign the ICF and follow the requirements specified in the protocol. * Age: ≥18 years and ≤75 years, both genders * Expected survival time≥12 weeks * Phase Ia: Patients with histologically and cytologically confirmed advanced or metastatic solid tumor * Phase Ib: Patients with histologically and cytologically confirmed EGFR-positive advanced or metastatic colorectal cancer, squamous cell carcinoma of head and neck, and nasopharyngeal carcinoma * Subjects must have measurable lesions according to the response Evaluation Criteria In Solid Tumors（RECIST v1.1） * ECOG performance score 0 or 1 * Acceptable liver, renal, and hematologic function * Patients with childbearing potential must use effective contraception during the treatment and for 6 months after the last dose of treatment Exclusion Criteria: * History of hypersensitivity to any component of the investigational product * Presence of central nervous system metastasis * Prior history of other primary malignancies * Known history of clinically significant hepatic diseases * Evidence of active infection of human immunodeficiency virus (HIV) * History of ophthalmic abnormalities * Any severe or uncontrolled systemic disease judged by the investigator * Patients with poorly controlled heart diseases * Received radiotherapy, chemotherapy, biotherapy, immunotherapy or other anti-tumor drugs within 4 weeks prior to the first dose of study treatment * Major surgery or surgical therapy for any cause within 4 weeks prior to the first dose of investigational drug * Planned surgery or surgery is the best interest of patients as determined by investigator * History of severe skin disease requiring interruption of previous EGFR targeted therapy; or chronic skin disease requiring oral or intravenous therapy * Active concomitant diseases that might increase risks of toxicity * Pregnancy, or breast feeding