Evaluating GNC-077 for advanced lung cancer and solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Caicun Zhou, PHD — Shanghai East Hospital
• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: 15013238943

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• First-in-human test of HH160 in people with advanced solid tumors

  HH160 is being tested to see if it is safe and how it behaves in the body, to see if it has early signs of helping various advanced cancers in adults.

  Recruiting at 3 sites Phase 1 Huahui Health · Waratah, New South Wales and 2 other locations · NCT07623369

• IBI3028 in advanced solid tumors

  This phase 1 study tests IBI3028 in adults with unresectable or metastatic solid tumors to see if it is safe and how patients tolerate it.

  Recruiting Phase 1 Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Tianjin, Tianjin Municipality · NCT07589205

• OCT-598 for advanced solid tumors

  This trial tests whether OCT-598, by itself or with docetaxel, is safe and to find the best dose for adults with advanced solid tumors who have limited standard treatment options.

  Recruiting at 2 sites Phase 1 Oscotec Inc. · Goyang-si and 2 other locations · NCT07358806

• PT0511 for advanced solid tumors with KRAS mutations or amplifications

  This trial tests whether the drug PT0511, given alone or with cetuximab for colorectal cancer, is safe and tolerable in adults with advanced solid tumors that have KRAS mutations or KRAS amplification.

  Recruiting at 9 sites Phase 1 PAQ Therapeutics, Inc. · Boston, Massachusetts and 8 other locations · NCT07300150

• BL-M24D1 for adults with advanced or metastatic non-small cell lung cancer and other solid tumors

  This trial will test whether BL-M24D1 is safe, how the body handles it, and whether it shows signs of benefit in adults with locally advanced or metastatic non-small cell lung cancer or other solid tumors.

  Recruiting Phase 1 Sichuan Baili Pharmaceutical Co., Ltd. · Guangzhou, Guangdong · NCT07232420

• Finding a suitable dose of ASP5834 for adults with solid tumors

  This trial tests different doses of the experimental drug ASP5834, given alone or with panitumumab, in adults whose advanced solid tumors have certain KRAS mutations to find a safe, tolerable dose.

  Recruiting at 22 sites Phase 1 Astellas Pharma Inc · Santa Monica, California and 21 other locations · NCT07094204

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.