A Study of GNC-077 in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer and Other Solid Tumors

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

NCT ID: NCT06612840

Condition: Non-small Cell Lung Cancer
Solid Tumor

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung

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 non-small cell lung 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 non-small cell lung 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; 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 trial 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: Shanghai East Hospital

Address:
City: Shanghai
Country: China

Contact:
Last name: Caicun Zhou

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/NCT06612840