A Phase I Clinical Study of YN003 in the Treatment of Glioma
Glioma · Glioblastoma · Brain Neoplasms
De qué trata este estudio
El registro indica que este estudio recluta participantes. La disponibilidad puede variar por centro.
- Tipo de estudio
- De intervención
- Fase
- Fase 1
- Rango de edad
- 18 años - 70 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 50 Estimado
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Acerca de la investigación
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).
Leer la descripción completa
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.
¿Quién podría participar?
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Inclusion Criteria:
- Voluntarily sign the informed consent form, understand the study, and be willing to comply with the protocol and complete all study procedures.
- Male or female subjects 18 years ≤ aged ≤ 70 years.
- Histologically confirmed recurrent or progressive glioma, including glioblastoma, as defined by the 2021 WHO Classification of Tumors of the Central Nervous System, Grade 3 to Grade 4, following standard therapy.Excluding re-irradiation for same lesions
- Karnofsky Performance Status (KPS) ≥60.
- At least one measurable lesion per RANO 2.0 criteria.
- Have adequate hematologic, cardiac, hepatic, renal, coagulation, and pulmonary function at final screening.
- Have completed the required washout period for prior therapies before dosing on Day 1.
- Corticosteroid dose must be stable or tapering within 7 days prior to dosing.
Exclusion Criteria:
- Participation in another interventional clinical study within 1 month prior to the date when subject signed the consent form.
- Receipt of a live vaccine within 30 days prior to study treatment.
- Pregnant or breastfeeding women.
- Clinically significant intracranial hypertension (e.g., impending brain herniation or requiring urgent palliative intervention) or uncontrolled seizures. Subjects requiring antiepileptic drugs are eligible only if the dose has been stable for ≥ 14 days prior to first dosing
- Toxicities from prior anticancer therapy that have not recovered to CTCAE v6.0 Grade ≤1, except for alopecia or other events considered tolerable by the investigator.
- Contraindications to MRI, including but not limited to pacemakers, epicardial pacing leads, infusion pumps, aneurysm clips, metal fragments, metallic prostheses, magnetic implants, intraocular metal objects, or non-removable metallic dental implants.
- Uncontrolled or severe cardiovascular or cerebrovascular disease
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- No aplica
- Enmascaramiento
- Sin enmascaramiento
Study Drug： YN003 Injection
Single-arm, open-label study of YN003 administered by intravenous infusion once every 4 weeks.
Drug: YN003 Injection
YN003 Injection DRUG
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.
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
To Incidence and characteristics of AEs/SAEs；
Plazo: From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first)
Assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.
Incidence of clinically significant abnormalities in laboratory tests
Plazo: From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first)
Percentage of participants with clinically significant abnormalities in hematology, blood chemistry, urinalysis, and coagulation lipid, Thyroid function.
Incidence of clinically significant abnormalities in vital signs
Plazo: From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first)
Percentage of participants with clinically significant abnormalities in body temperature, respiratory rate, blood pressure, pulse rate, and oxygen saturation.
Incidence of clinically significant abnormalities in physical examinations
Plazo: From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first)
Percentage of participants with clinically significant abnormalities in general physical examinations and neurological examinations.
Change from baseline in 12-lead Electrocardiogram (ECG) parameters
Plazo: From first dose of YN003 to 30 days after the last dose (or initiation of new antitumor therapy, whichever occurs first)
To Incidence and characteristics of Clinically significant changes of ECG The ECG evaluation must include heart rate, QT interval, QTcF, and PR interval.
To assess the tolerability of YN003 in subjects with recurrent/progressive glioma (WHO grade 3 - 4)
Plazo: First 28 days after the first dose of YN003 MTD：During dose escalation (Part A), approximately 21-30 DLT-evaluable subjects]
Dose-limiting toxicity (DLT) Maximum tolerated dose (MTD)
Medidas secundarias
Peak Plasma Concentration (Cmax) and Time to Peak Plasma Concentration (Tmax) of YN003
Plazo: Up to 28 days of post initiation of last dose
Maximum observed plasma concentration (Cmax) and time to reach maximum observed plasma concentration (Tmax).
Area Under the Plasma Concentration-Time Curve (AUC) of YN003
Plazo: Up to 28 days of post initiation of last dose
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-∞).
Terminal Half-life (t1/2), Clearance (CL), and Volume of Distribution (Vd) of YN003
Plazo: Up to 28 days of post initiation of last dose
Terminal elimination half-life, total body clearance, and apparent volume of distribution.
Overall Survival (OS)
Plazo: From 1st dose to death from any cause, assessed at 6 and 12 months after first dose.
OS rates at 6 and 12 months.
Progression-Free Survival (PFS)
Plazo: 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.
PFS rates at 6 and 12 months, assessed by the investigator per RANO 2.0 criteria.
Objective Response Rate (ORR)
Plazo: From first dose until disease progression or initiation of new antitumor therapy (estimated up to 2 years).
Percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per RANO 2.0 criteria.
Duration of Response (DoR)
Plazo: From the date of 1st dose to the date of first documented disease progression or death (estimated up to 1 year).
Time from the first documented objective response to the date of first documented disease progression or death from any cause, whichever comes first.
Disease Control Rate (DCR)
Plazo: From first dose until disease progression or initiation of new antitumor therapy (estimated up to 2 years).
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.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (5)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
5 centros
University of California, Los Angeles (UCLA)Los Angeles, California, United StatesAún no recluta
University of California, San Francisco (UCSF)San Francisco, California, United StatesAún no recluta
The University of Texas MD Anderson Cancer CenterHouston, Texas, United StatesAún no recluta
Beijing Tsinghua Changgung HospitalBeijing, Beijing Municipality, ChinaReclutando
Sanbo Brain Hospital, Capital Medical UniversityBeijing, Beijing Municipality, ChinaReclutando
Equipo y fechas
- Patrocinador principal
- Beijing Inno Medicine Co., Ltd.
- Inicio del estudio
- 27 oct 2026 Real
- Finalización primaria
- 31 dic 2028 Estimado
- Finalización del estudio
- 31 dic 2029 Estimado
- Primera publicación
- 10 nov 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
Título oficial del estudio
A Phase 1, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of YN003 Injection in Patients With Glioma
Consulta a Wellness Clinical Research
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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026