Trials Sponsors Conditions Drugs Pricing

Conditions

Advanced Solid Tumor NSCLC

Keywords

Non-small cell lung cancer (NSCLC)Pulmonary metastaseslung metastasesAdenovirusnebulization

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-01Biological

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)

YSCH-01Biological

YSCH-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.

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Shanghai Yuansong Biotechnology Co., Ltd.
Industrycollaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Otherlead

Study Sites (1)

No.17 Panjiayuan Nanli, Chaoyang District, Beijing

Beijing, 100021, China

RECRUITING

CONTACTcancergcp@163.com

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungAdenoviridae Infections

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesDNA Virus InfectionsVirus DiseasesInfections

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

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

Study Record Dates

First Submitted

March 28, 2026

First Posted

August 28, 2026

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.
+11 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

YSCH-01 at Dose Level 1 (2.0×10¹¹ VP)

YSCH-01 at Dose Level 2 (4.0×10¹¹ VP)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (2)

YSCH-01 at Dose Level 1 (2.0×10¹¹ VP)

YSCH-01 at Dose Level 2 (4.0×10¹¹ VP)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations