A Phase 1 interventional study of YN003 Injection in Glioma, Glioblastoma and Brain Neoplasms, sponsored by Beijing Inno Medicine Co., Ltd.. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Beijing Inno Medicine Co., Ltd. · Phase 1, Interventional, and Treatment
This is a Phase 1, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of YN003 Injection in patients with recurrent or progressive glioma. The study consists of Part A (dose escalation using a Bayesian Optimal Interval design) and Part B (dose expansion at the recommended Phase 2 dose).
YN003 is an investigationalliposome injection designed to deliver the active drug preferentially to specific glioma tissue. Part A will evaluate ascending doses of YN003 administered by intravenous infusion once every 4 weeks to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The dose-limiting toxicity (DLT) observation period is 28 days. Approximately 21 to 30 DLT-evaluable subjects will be enrolled in Part A. Part B will enroll approximately 10 to 20 additional subjects at the RP2D to further evaluate safety, pharmacokinetics, and preliminary efficacy. The study will be conducted in the United States and China.
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's planned enrollment of 50 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Beijing Inno Medicine Co., Ltd. is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Compared within Glioblastoma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Glioma. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single-arm, open-label study of YN003 administered by intravenous infusion once every 4 weeks.
Drug: YN003 Injection
YN003 is an investigational liposome injection designed to deliver the drug preferentially to specific glioma tissue. Part A will evaluate ascending doses of YN003 administered by intravenous infusion once every 4 weeks to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The dose-limiting toxicity (DLT) observation period is 28 days. Approximately 21 to 30 DLT-evaluable subjects will be enrolled in Part A. Part B will enroll approximately 10 to 20 additional subjects at the RP2D to further evaluate safety, pharmacokinetics, and preliminary efficacy. The study will be conducted in the United States and China.
To Incidence and characteristics of AEs/SAEs；
Assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.
Time frame: From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first)
Incidence of clinically significant abnormalities in laboratory tests
Percentage of participants with clinically significant abnormalities in hematology, blood chemistry, urinalysis, and coagulation lipid, Thyroid function.
Time frame: From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first)
Incidence of clinically significant abnormalities in vital signs
Percentage of participants with clinically significant abnormalities in body temperature, respiratory rate, blood pressure, pulse rate, and oxygen saturation.
Time frame: From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first)
Incidence of clinically significant abnormalities in physical examinations
Percentage of participants with clinically significant abnormalities in general physical examinations and neurological examinations.
Time frame: From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first)
Change from baseline in 12-lead Electrocardiogram (ECG) parameters
To Incidence and characteristics of Clinically significant changes of ECG The ECG evaluation must include heart rate, QT interval, QTcF, and PR interval.
Time frame: From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first)
To assess the tolerability of YN003 in subjects with recurrent/progressive glioma (WHO grade 3 - 4)
Dose-limiting toxicity (DLT) Maximum tolerated dose (MTD)
Time frame: First 28 days after the first dose of YN003 MTD：During dose escalation (Part A), approximately 21-30 DLT-evaluable subjects]
Peak Plasma Concentration (Cmax) and Time to Peak Plasma Concentration (Tmax) of YN003
Maximum observed plasma concentration (Cmax) and time to reach maximum observed plasma concentration (Tmax).
Time frame: Up to 28 days of post initiation of last dose
Area Under the Plasma Concentration-Time Curve (AUC) of YN003
Area under the plasma concentration versus time curve from time zero to the last quantifiable time point (AUC0-t) and from time zero to infinity (AUC0-∞).
Time frame: Up to 28 days of post initiation of last dose
Terminal Half-life (t1/2), Clearance (CL), and Volume of Distribution (Vd) of YN003
Terminal elimination half-life, total body clearance, and apparent volume of distribution.
Time frame: Up to 28 days of post initiation of last dose
Overall Survival (OS)
OS rates at 6 and 12 months.
Time frame: From 1st dose to death from any cause, assessed at 6 and 12 months after first dose.
Progression-Free Survival (PFS)
PFS rates at 6 and 12 months, assessed by the investigator per RANO 2.0 criteria.
Time frame: From 1st dose until the date to first documented disease progression or death from any cause, whichever comes first, assessed at 6 and 12 months after first dose.
Objective Response Rate (ORR)
Percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per RANO 2.0 criteria.
Time frame: From first dose until disease progression or initiation of new antitumor therapy (estimated up to 2 years).
Duration of Response (DoR)
Time from the first documented objective response to the date of first documented disease progression or death from any cause, whichever comes first.
Time frame: From the date of 1st dose to the date of first documented disease progression or death (estimated up to 1 year).
Disease Control Rate (DCR)
Percentage of participants with a confirmed complete response (CR), partial response (PR), or stable disease (SD) as assessed by the investigator per RANO 2.0 criteria.
Time frame: From first dose until disease progression or initiation of new antitumor therapy (estimated up to 2 years).
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Beijing Inno Medicine Co., Ltd.