TrialBridgeNCT06609187
A Study of GNC-077 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Recruiting · Phase 1 · Sichuan Baili Pharmaceutical Co., Ltd. · registry updated 2026-01-21
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- 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;
Exclusion
- Chemotherapy, biological therapy, immunotherapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
- Patients with active infection requiring intravenous antibiotics who did not complete treatment within 1 week before enrollment, except prophylactic antibiotics for puncture or biopsy;
- Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection;
- No reduction in toxicity from previous antineoplastic therapy to grade I as defined in CTCAE, version 5.0, or to the level specified in the inclusion criteria;
- Patients at risk for active autoimmune disease or with a history of autoimmune disease may have central nervous system involvement;
- Pulmonary disease defined as ≥ grade 3 according to NCI-CTCAE v5.0; A history of ILD requiring steroid therapy, or current ILD or grade ≥2 radiation pneumonitis;