An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics or Preliminary Efficacy and Antitumor Activity of GNC-077 Multi-specific Antibody Injection in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
This study is an open-label, multicenter, dose-escalation and cohort expansion phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics or preliminary efficacy and antitumor activity in patients with locally advanced or metastatic breast cancer and other solid tumors.
• Able to understand the informed consent form, voluntarily participate in and sign the informed consent form;
• Gender is not limited;
• Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
• Locally advanced or metastatic breast cancer and other solid tumors;
• Must have at least one measurable lesion that meets the RECIST v1.1 definition;
• Have archived primary or recurrent tumor tissue specimens that can be submitted for central review;
• ECOG ≤1;
• The expected survival time as judged by the investigators was ≥3 months;
• Bone marrow function, renal function and liver function should meet the requirements;
⁃ Coagulation function: fibrinogen ≥1.5g/L; Activated partial thromboplastin time (APTT) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN;
⁃ Fertile female subjects or male subjects with fertile partners must use highly effective contraception from 7 days before the first dose until 12 weeks after the last dose. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose;
⁃ Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.