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.
The subject has received chemotherapy or antibody therapy, molecular targeted therapy, hormone therapy, therapeutic or palliative radiotherapy within 21 days before the first dose, has received anti-tumor traditional Chinese medicine therapy within 1 week before the first dose, or has received immune checkpoint inhibitors (e.g., PD-1, PD-L1 monoclonal antibodies) within 42 days.
The subject has experienced cardiac-related adverse reactions, or ≥Grade 3 immune-related adverse events (irAEs) or severe irAEs (excluding skin or endocrine irAEs that have recovered to Grade 1 or normal after treatment), or >Grade 2 cytokine release syndrome (CRS) from prior anti-tumor therapy.
The subject has systemic diseases that are not stably controlled after treatment, such as diabetes, severe organic cardiovascular or cerebrovascular diseases, hypertension, second-degree or higher atrioventricular block, myocardial infarction within the past 6 months, or cerebral infarction within the past 6 months.
The subject has uncontrolled infectious diseases, active hepatitis B (positive for anti-hepatitis B core (HBc) antibody and hepatitis B virus (HBV)-DNA > the lower limit of detection(LLOD) of the study center); active hepatitis C (positive for anti-hepatitis C virus (HCV) antibody and HCV RNA > LLOD); or positive for anti-human immunodeficiency virus (HIV)-1 or HIV-2 antibodies.
Sequential
YSCH-01
Biological/VaccineYSCH-01, 2.0×10¹¹ VP, inhalation via nebulizer; the second administration is to be given 21 days after the first administration, and then once weekly thereafter.
YSCH-01
Biological/VaccineYSCH-01, 4.0×10¹¹ VP, inhalation via nebulizer; the second administration is to be given 21 days after the first administration, and then once weekly thereafter.
Incidence and characteristics of AE/SAE
Type, frequency, severity, and relationship to study treatment of AEs and SAEs assessed per NCI-CTCAE v5.0
Incidence of Dose Limiting Toxicities (DLT)
The proportion of subjects who experienced the defined DLT as per the protocol during the DLT observation period after receiving YSCH-01 treatment
Determine the maximum tolerated dose (if applicable)
Maximum tolerated dose is defined as the highest dose level with a DLT incidence rate ≤ 1/6 per standard "3+3" dose escalation rules.
Objective Response Rate (ORR)
The proportion of subjects who achieved confirmed CR or PR during the period from the first dose up to 12 months following the last dose of study treatment, and who did not initiate any new anticancer therapy within 12 months after the last dose of study treatment. Tumor assessments will be performed every 6 weeks after the first dose during treatment. For subjects who discontinue study treatment without disease progression, tumor assessments will be conducted every 12 weeks thereafter until disease progression, initiation of new anticancer therapy, withdrawal of informed consent, death, or 12 months following the last dose of study treatment, whichever occurs first.
Disease Control Rate (DCR)
The proportion of patients whose tumor assessment reached SD, PR or CR during the research process among the total number of enrolled patients; The patients whose tumor assessment reached SD, PR or CR include the following types: 1. Subjects who were evaluated as SD, PR or CR during the study treatment; 2. Subjects who were not PD and were excluded from the study, and after exclusion, did not receive other anti-tumor drug treatment, and whose tumors were evaluated as SD, PR or CR. (For subjects excluded due to non-PD, a tumor assessment will be conducted every 12 weeks until disease progression, initiation of new anti-cancer treatment, withdrawal of informed consent, death, or 12 months after the last study treatment administration, whichever occurs earlier.
progression free survival (PFS)
The period from the first dose to the date of the first occurrence of disease progression or death due to any cause
overall survival (OS)
The period from the time of the first dose to the date of death due to any cause by the subject
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead sponsor
Shanghai Yuansong Biotechnology Co., LTD
Collaborator
