Status:
RECRUITING
A Study of GNC-077 in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer and Other Solid Tumors
Lead Sponsor:
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions:
Non-small Cell Lung Cancer
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
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 non-small cell lung 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;
- ECOG ≤1;
- The expected survival time as judged by the investigators was ≥3 months;
- Bone marrow function, renal function and liver function should meet the requirements;
- Coagulation function: fibrinogen ≥1.5g/L; Activated partial thromboplastin time (APTT) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN;
- 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;
- Subjects were able and willing to comply with protocol-specified visits, treatment plans, laboratory tests, and other study-related procedures.
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;
- 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;
- Patients with previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
- Had a history of severe cardiovascular and cerebrovascular diseases;
- Patients had or had thrombotic events such as deep vein thrombosis, arterial thrombosis and pulmonary embolism within 6 months before screening;
- Brain parenchymal metastases and/or meningeal metastases or spinal cord compression, excluding stable and asymptomatic brain parenchymal metastases;
- Uncontrolled pleural effusion with clinical symptoms who were judged by the investigator to be ineligible for enrollment;
- Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
- Who had participated in a clinical trial of an unmarketed drug within 4 weeks before the trial dose;
- Had received a live vaccine within 4 weeks before the trial dose;
- Other circumstances that the investigator deemed inappropriate for participation in the trial.
Key Trial Info
Start Date :
October 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06612840
Start Date
October 16 2024
End Date
October 1 2026
Last Update
November 21 2024
Active Locations (1)
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1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China