Evaluating GNC-077 for advanced lung cancer and solid tumors

An Open-label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics or Preliminary Efficacy and Antitumor Activity of GNC-077 Multi-specific Antibody Injection in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Other Solid Tumors

This study is testing a new drug called GNC-077 to see if it is safe and effective for people with advanced lung cancer and other solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Chemotherapy, immunotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06612840 on ClinicalTrials.gov

What this trial studies

This is an open-label, multicenter, dose-escalation phase I clinical study designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of GNC-077 in patients with locally advanced or metastatic non-small cell lung cancer and other solid tumors. The study will involve participants who have measurable lesions and will monitor their response to the treatment. The goal is to gather data that could inform future studies and potential therapeutic applications of GNC-077.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with locally advanced or metastatic non-small cell lung cancer or other solid tumors who have measurable lesions.

Not a fit: Patients with early-stage cancer or those who do not meet the eligibility criteria, such as poor organ function or insufficient survival prognosis, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced lung cancer and solid tumors.

How similar studies have performed: While this study is exploring a novel treatment approach, similar studies have shown promise in targeting advanced cancers with new therapies.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Caicun Zhou, PHD — Shanghai East Hospital
• Study coordinator: Sa Xiao, PHD

Conditions Non-small Cell Lung Cancer; Solid Tumor