Search / Trial NCT06612840

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

Launched by SICHUAN BAILI PHARMACEUTICAL CO., LTD. · Sep 23, 2024

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Trial Information

Current as of December 22, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called GNC-077 for patients with locally advanced or metastatic non-small cell lung cancer and other types of solid tumors. The main goal is to see how safe the treatment is, how well it works, and how the body processes it. The trial is currently looking for participants aged 18 to 75 who have measurable cancer lesions and meet certain health criteria. Eligible participants should not have had recent cancer treatments or certain medical conditions that could complicate their participation.

If you join this study, you will receive GNC-077 and be closely monitored by the research team to check for any side effects and to see how your cancer responds to the treatment. You will need to attend regular visits for health assessments and tests as part of the trial. It’s important to note that this study is open to everyone, regardless of gender, and participants will need to follow specific guidelines regarding contraception and health management throughout the trial. This could be an opportunity to access a new treatment option while contributing to valuable research in cancer care.

Gender

ALL

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.

Trial Officials

Caicun Zhou, PHD

Principal Investigator

Shanghai East Hospital

About Sichuan Baili Pharmaceutical Co., Ltd.

Sichuan Baili Pharmaceutical Co., Ltd. is a leading pharmaceutical company based in China, dedicated to the research, development, and production of innovative healthcare solutions. With a strong focus on enhancing patient outcomes, the company specializes in a diverse range of therapeutic areas, including oncology, cardiovascular diseases, and infectious diseases. Sichuan Baili is committed to adhering to the highest standards of quality and regulatory compliance, leveraging advanced technologies and a robust R&D pipeline to bring novel therapies to market. Through strategic collaborations and clinical trials, the company aims to address unmet medical needs and improve the overall health and well-being of patients globally.

Locations

Shanghai, Shanghai, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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