An Open-label, Single-center Study to Evaluate the Dose Escalation and Cohort Expansion of YSCH-01 in Subjects With Pulmonary Metastasis of Advanced Solid Tumors and Advanced Non-small Cell Lung Cancer by Nebulized Inhalation Administration
This is an open-label, dose-escalation and cohort expansion study to evaluate the safety and preliminary efficacy of YSCH-01 in subjects with pulmonary metastasis of advanced solid tumors and advanced non-small cell lung cancer by nebulized inhalation administration. This study is consisting of two phases: the dose escalation phase and the cohort expansion phase.
• Subjects are able to understand and comply with protocol requirements, in the investigator's judgment.
• Subjects are willing to sign the informed consent form (ICF) before any study procedures are initiated.
• Male or female patients aged ≥18 years old and ≤75 years old.
• Dose escalation phase: Subjects with histologically or cytologically confirmed advanced unresectable/relapsed metastatic non-small cell lung cancer (NSCLC) or advanced solid tumors with lung metastases who have failed prior standard therapy, have no standard therapy or are not eligible for standard therapy.
• Cohort expansion phase:
⁃ Cohort 1: Subjects with advanced unresectable or metastatic NSCLC who have failed prior immunotherapy and/or platinum-based chemotherapy, including:
⁃ Those with driver gene mutations positive for which no targeted therapy is approved;
⁃ Those without driver gene mutations.
⁃ Cohort 2: Subjects with histologically or cytologically confirmed relapsed sarcoma with lung metastases after surgical resection (lung metastases only).
⁃ Cohort 3: Subjects with histologically or cytologically confirmed relapsed hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), or other sensitive tumors with lung metastases after surgical resection (lung metastases only).
• Subjects with relapsed, refractory, or locally advanced lesions are eligible; subjects with curable or resectable lesions are not eligible.
• Subjects must have at least one measurable lesion as defined by RECIST 1.1, i.e., non-lymph node lesions with a long diameter ≥10 mm or a lymph node lesion with a short diameter ≥15 mm on cross-sectional imaging (CT or MRI).
• Pulmonary function test: FEV1/expected FEV1 ≥50% and FVC ≥50% of expected value.
• Subjects have adequate hematologic, hepatic, renal, and coagulation function.
• Eligible subjects of childbearing potential (male and female) must agree to use reliable contraceptive methods during the study and for at least six months after the last dose.
⁃ Women of childbearing potential must have a negative pregnancy test within 7 days before starting treatment.
⁃ Subjects with an eastern cooperative oncology group (ECOG) score of 0-1 and an expected survival of at least 12 weeks.
⁃ All adverse events (AEs) from prior treatment or surgery must have recovered to Grade 1 or baseline.