A Study of GNC-077 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

Trial Title: A Study of GNC-077 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors

NCT ID: NCT06609187

Condition: Breast Cancer
Solid Tumor

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: GNC-077
Description: Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label: GNC-077

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.

Criteria for 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 childbearing potential must have a negative serum pregnancy test within 7 days before the first dose; 12. Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures. Exclusion Criteria: 1. 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; 2. Patients with active infection requiring intravenous antibiotics who did not complete treatment within 1 week before enrollment, except prophylactic antibiotics for puncture or biopsy; 3. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection or hepatitis C virus infection; 4. 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; 5. Patients at risk for active autoimmune disease or with a history of autoimmune disease may have central nervous system involvement; 6. 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; 7. Patients with previous allogeneic hematopoietic stem cell transplantation or organ transplantation; 8. Had a history of severe cardiovascular and cerebrovascular diseases; 9. Patients had or had thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism within 6 months before screening; 10. Brain parenchymal metastases and/or meningeal metastases or spinal cord compression, excluding stable and asymptomatic brain parenchymal metastases; 11. Uncontrolled pleural effusion with clinical symptoms who were judged by the investigator to be ineligible for enrollment; 12. Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg); 13. Who had participated in a clinical trial of an unmarketed drug within 4 weeks before the study dose (counted as the end of the last dose); 14. Had received a live vaccine within 4 weeks before the trial dose; 15. Other circumstances that the investigator deemed inappropriate for participation in the trial.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Cancer Hospital Chinese Academy of Medical Sciences

Address:
City: Beijing
Country: China

Contact:
Last name: Binghe Xu

Start date: October 2024

Completion date: October 2026

Lead sponsor:
Agency: Sichuan Baili Pharmaceutical Co., Ltd.
Agency class: Industry

Collaborator:
Agency: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class: Industry

Source: Sichuan Baili Pharmaceutical Co., Ltd.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06609187