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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат GNC-077
  Administration by intravenous infusion for a cycle of 3 weeks.

Первичные конечные точки

• Phase Ia: Dose limiting toxicity (DLT) [Срок оценки: Up to 21 days after the first dose]
• Phase Ia: Maximum tolerated dose (MTD) [Срок оценки: Up to 21 days after the first dose]
• Phase Ia: Treatment-Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• Phase Ib: Recommended Phase II Dose (RP2D) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (12)

• Cmax [Срок оценки: Up to approximately 24 months]
• Tmax [Срок оценки: Up to approximately 24 months]
• AUC0-inf [Срок оценки: Up to approximately 24 months]
• AUC0-t [Срок оценки: Up to approximately 24 months]
• CL (Clearance) [Срок оценки: Up to approximately 24 months]
• T1/2 [Срок оценки: Up to approximately 24 months]
• ADA (anti-drug antibody) [Срок оценки: Up to approximately 24 months]
• Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 24 months]
• Duration of Response (DOR) [Срок оценки: Up to approximately 24 months]
• Progression-free survival (PFS) [Срок оценки: Up to approximately 24 months]
• Overall survival (OS) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai East Hospital — Шанхай

Идентификаторы

NCT: NCT06612840 · GNC-077-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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