A Study of GNC-077 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Able to understand the informed consent form, voluntarily participate in and sign the informed consent form; 2. Gender is not limited; 3. Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib); 4. Locally advanced or metastatic breast cancer and other solid tumors; 5. Must have at least one measurable lesion that meets the RECIST v1.1 definition; 6. Have archived primary or recurrent tumor tissue specimens that can be submitted for central review; 7. ECOG ≤1; 8. The expected survival time as judged by the investigators was ≥3 months; 9. Bone marrow function, renal function and liver function should meet the requirements; 10. Coagulation function: fibrinogen ≥1.5g/L; Activated partial thromboplastin time (APTT) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN; 11. 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