NSCLCEarly Phase 1NCT07793500
YSCH-01 Via Nebulization in Pulmonary Metastasis of Advanced Solid Tumors and Non-small Cell Lung Cancer (NSCLC)
A Early Phase 1 study testing YSCH-01 in people with NSCLC and Advanced Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NSCLC, Advanced Solid Tumor
- What is being tested?
- YSCH-01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2025to 30 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
- The subject has active autoimmune disease or a history of autoimmune disease with potential for recurrence, such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, or granulomatosis with polyangiitis (Wegener's granulomatosis). Subjects with the following conditions are permitted: autoimmune hypothyroidism requiring only hormone replacement therapy; skin diseases not requiring systemic treatment (e.g., eczema involving <10% of body surface area).
- The subject has a known allergy to any component of the study drug or immunotherapy.
- The subject has a past or current history of organ dysfunction.
- The subject requires systemic corticosteroids (equivalent to >10 mg prednisone/day) within 14 days before enrollment or during the study period. Subjects are eligible for cohort enrollment in the following cases: topical (excluding inhaled) corticosteroid use, or short-term (≤7 days) use of glucocorticoids to prevent or treat non-autoimmune allergic conditions.
- History of pulmonary fibrosis, or current interstitial pneumonia, pneumoconiosis, chemical pneumonia, or other severe pulmonary function impairment, or conditions that make nebulized administration difficult due to prior medical history, such as asthma, airway obstruction, etc.
- Current presence of uncontrolled pleural effusion, pericardial effusion, or ascites.
- The subject lacks legal capacity or has limited legal capacity and is unable to complete informed consent.
- The subject has participated in another clinical trial of a drug or medical device within the previous 4 weeks or 5 half-lives, whichever is shorter.
- The subject has severe and uncontrolled disease or other conditions that may affect their participation in this study, as determined by the investigator.
- The subject is pregnant or breastfeeding.
- The subject receives any live vaccine during the screening period or treatment period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
LI NING Vice President of Cancer Hospital, Chinese Academy of Medical, Doctorate contact
China1 site, 1 recruiting
- Recruiting
No.17 Panjiayuan Nanli, Chaoyang District, Beijing
Beijing, 100021
cancergcp@163.com
About this study
Official title: 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.
Read the detailed description
In dose escalation phase, subjects with pulmonary metastasis of advanced solid tumors and advanced non-small cell lung cancer 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. All the subjects received a single dose of YSCH-01 treatment, followed by a 21-day DLT observation period. If no DLT occurred, the YSCH-01 will administered once a week thereafter until the investigator deemed that the subjects no longer benefited significantly, experienced intolerable toxicity, withdrew their informed consent, had disease progression, died, were lost to follow-up, or the investigator deemed that terminating the treatment was in the best interest of the subjects (whichever occurred first).
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.
- Conditions
- NSCLC, Advanced Solid Tumor
- Being tested
- YSCH-01
- Keywords
- Non-small cell lung cancer (NSCLC), Pulmonary metastases, lung metastases, Adenovirus, nebulization
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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-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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: YSCH-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and characteristics of AE/SAE
Type, frequency, severity, and relationship to study treatment of AEs and SAEs assessed per NCI-CTCAE v5.0
Measured: 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
Measured: 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.
Measured: Within 21 days following the date of the first administration of YSCH-01
Secondary outcomes (4)
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.
Measured: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
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:
- Subjects who were evaluated as SD, PR or CR during the study treatment;
- 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.
Measured: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
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
Measured: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
overall survival (OS)
The period from the time of the first dose to the date of death due to any cause by the subject
Measured: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start27 Nov 2025
- Primary completion9 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Yuansong Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, NING LI, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Shuhang Wang, Study director, NCC, CICAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793500
- Sponsor's protocol ID
- YSCH-01-IIT-CN001
- Status last verified
- Jul 2026
- First submitted
- 28 Mar 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07793500
- Acronym / sponsor ID
- YSCH-01-IIT-CN001
- Conditions
- NSCLC, Advanced Solid Tumor
- Keywords
- Non-small cell lung cancer (NSCLC), Pulmonary metastases, lung metastases, Adenovirus, nebulization
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Shanghai Yuansong Biotechnology Co., Ltd.
- Study start
- 27 Nov 2025 (actual)
- Primary completion
- 9 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In dose escalation phase, subjects with pulmonary metastasis of advanced solid tumors and advanced non-small cell lung cancer 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. All the subjects received a single dose of YSCH-01 treatment, followed by a 21-day DLT observation period. If no DLT occurred, the YSCH-01 will administered once a week thereafter until the investigator deemed that the subjects no longer benefited significantly, experienced intolerable toxicity, withdrew their informed consent, had disease progression, died, were lost to follow-up, or the investigator deemed that terminating the treatment was in the best interest of the subjects (whichever occurred first).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| YSCH-01 at Dose Level 1 (2.0×10¹¹ VP) | Experimental | Biological: YSCH-01YSCH-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. |
| YSCH-01 at Dose Level 2 (4.0×10¹¹ VP) | Experimental | Biological: YSCH-01YSCH-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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
- Subjects with relapsed, refractory, or locally advanced lesions are eligible; subjects with curable or resectable lesions are not eligible.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YSCH-01YSCH-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. | Biological | YSCH-01 at Dose Level 1 (2.0×10¹¹ VP) |
| YSCH-01YSCH-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. | Biological | YSCH-01 at Dose Level 2 (4.0×10¹¹ VP) |
Primary outcome
Incidence and characteristics of AE/SAE
Time frame: From the date of first dose up to 28 days after the date of last dose
Type, frequency, severity, and relationship to study treatment of AEs and SAEs assessed per NCI-CTCAE v5.0
Incidence of Dose Limiting Toxicities (DLT)
Time frame: Within 21 days following the date of the first administration of YSCH-01
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)
Time frame: Within 21 days following the date of the first administration of YSCH-01
Maximum tolerated dose is defined as the highest dose level with a DLT incidence rate ≤ 1/6 per standard "3+3" dose escalation rules.
4 secondary outcomes
Objective Response Rate (ORR)
Time frame: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
Disease Control Rate (DCR)
Time frame: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
progression free survival (PFS)
Time frame: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
overall survival (OS)
Time frame: The maximum estimated time for each subject to undergo tumor assessment is 30 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LI NING Vice President of Cancer Hospital, Chinese Academy of Medical, Doctorate contact
Shuhang Wang study director
NCC, CICAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing YSCH-01 in people with NSCLC and Advanced Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LI NING Vice President of Cancer Hospital, Chinese Academy of Medical, Doctorate (+86-10-87788495, cancergcp@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and characteristics of AE/SAE (time frame: From the date of first dose up to 28 days after the date of last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.