YSCH-01 Via Nebulization in Pulmonary Metastasis of Advanced Solid Tumors and Non-small Cell Lung Cancer (NSCLC)

NCT07793500 | Recruiting Early Phase 1

• 1 other identifier: YSCH-01-IIT-CN001
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

NSCLC; Advanced Solid Tumor

Keywords

Non-small cell lung cancer (NSCLC); Pulmonary metastases; lung metastases; Adenovirus; nebulization

Outcome Measures

Primary Outcomes (3)

• Incidence and characteristics of AE/SAE

  Type, frequency, severity, and relationship to study treatment of AEs and SAEs assessed per NCI-CTCAE v5.0

  From the date of first dose up to 28 days after the date of last dose

• 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

  Within 21 days following the date of the first administration of YSCH-01

• 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.

  Within 21 days following the date of the first administration of YSCH-01

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  The maximum estimated time for each subject to undergo tumor assessment is 30 months.

• Disease Control Rate (DCR)

  The maximum estimated time for each subject to undergo tumor assessment is 30 months.

• progression free survival (PFS)

  The maximum estimated time for each subject to undergo tumor assessment is 30 months.

• overall survival (OS)

  The maximum estimated time for each subject to undergo tumor assessment is 30 months.

Study Arms (2)

YSCH-01 at Dose Level 1 (2.0×10¹¹ VP)

EXPERIMENTAL

YSCH-01 is administered via nebulization inhalation at a dose of 2.0×10¹¹ VP per administration. Following the first administration, there is a 21-day DLT observation period before the second dose. Dosing is performed once weekly starting from the third administration.

Biological: YSCH-01

YSCH-01 at Dose Level 2 (4.0×10¹¹ VP)

EXPERIMENTAL

YSCH-01 is administered via nebulization inhalation at a dose of 4.0×10¹¹ VP per administration. Following the first administration, there is a 21-day DLT observation period before the second dose. Dosing is performed once weekly starting from the third administration.

Biological: YSCH-01

Interventions

YSCH-01 BIOLOGICAL

YSCH-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 at Dose Level 1 (2.0×10¹¹ VP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• The subject has uncontrolled active infection of ≥Grade 3 with significant clinical relevance according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0.
• The subject has had other malignancies within the past 5 years, excluding basal cell or squamous cell carcinoma of the skin that has been cured by radical resection, or carcinoma in situ of the cervix.
• The subject has lesions located in high-risk positions (including those near the airways, major blood vessels, etc.) that may cause occlusion or compression due to tumor enlargement, or erosion into major vessels due to necrosis, or encasement of major vascular structures (e.g., pulmonary artery), or tumors adjacent to important neurovascular structures.
• Known symptomatic, untreated, or active central nervous system (CNS) metastases. Subjects with asymptomatic and previously treated brain metastases may participate provided that:
• Imaging is stable, i.e., no evidence of disease progression on imaging during the screening period (note: imaging should be performed after local therapy for CNS);
• Clinically stable with no history of intracranial hemorrhage or spinal cord hemorrhage;
• Does not require steroid therapy for at least 14 days before the first dose of study treatment;
• Has not received stereotactic radiotherapy within 7 days before the first dose, whole-brain radiotherapy within 14 days before the first dose, or neurosurgery within 28 days before the first dose;
• Metastases are limited to the cerebellum or supratentorial region (i.e., no metastases to the midbrain, pons, medulla oblongata, or spinal cord);
• Must have measurable disease outside the CNS.
• History of leptomeningeal disease.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Shanghai Yuansong Biotechnology Co., LTD: collaborator

Study Sites (1)

No.17 Panjiayuan Nanli, Chaoyang District, Beijing

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Adenoviridae Infections

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Shuhang Wang

  NCC, CICAMS

  STUDY DIRECTOR

Central Study Contacts

LI NING Vice President of Cancer Hospital, Chinese Academy of Medical, Doctorate

CONTACT

+86-10-87788495; cancergcp@163.com

Shuhang Wang

CONTACT

13552715820; snowflake201@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. Professor

Model Details: This study is consisting of two phases: the dose escalation phase and the cohort expansion phase. In dose escalation phase, subjects will be enrolled to receive YSCH-01 treatment by inhalation via nebulization. The "3+3" design will be adopted to explore the MTD and determine RP2D. Two dose groups will be established as follows: Dose group 1: 2E+11 VP; Dose group 2: 4E+11 VP. In cohort expansion phase, subjects will receive the optimal dose and administration schedule determined during the dose escalation phase. The cohort expansion phase further evaluated the safety and preliminary efficacy of YSCH-01 and planned to include 3 cohorts, with 10-30 subjects in each cohort.

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: August 28, 2026
• Study Start: November 27, 2025
• Primary Completion (Estimated): October 9, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)