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A Phase I Clinical Study of YN003 in the Treatment of Glioma

4. November 2026 aktualisiert von: Beijing Inno Medicine Co., Ltd.

A Phase 1, Open-Label, Single-Arm, Dose-Escalation and Dose-Expansion Study of YN003 Injection in Patients With Glioma

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).

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 102218
        • Rekrutierung
        • Beijing Tsinghua Changgung Hospital
        • Kontakt:
      • Beijing, Beijing Municipality, China
        • Rekrutierung
        • Sanbo Brain Hospital, Capital Medical University
        • Kontakt:
  • Vereinigte Staaten
    • California
      • Los Angeles, California, Vereinigte Staaten, 90095
        • Noch keine Rekrutierung
        • University of California, Los Angeles (UCLA)
        • Kontakt:
      • San Francisco, California, Vereinigte Staaten, 94158
        • Noch keine Rekrutierung
        • University of California, San Francisco (UCSF)
        • Kontakt:
    • Texas
      • Houston, Texas, Vereinigte Staaten, 77030
        • Noch keine Rekrutierung
        • The University of Texas MD Anderson Cancer Center
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Study Drug： YN003 Injection

Single-arm, open-label study of YN003 administered by intravenous infusion once every 4 weeks.
Arzneimittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
To Incidence and characteristics of AEs/SAEs；
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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
Zeitfenster: 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.
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)
Zeitfenster: 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)
First 28 days after the first dose of YN003 MTD：During dose escalation (Part A), approximately 21-30 DLT-evaluable subjects]

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Peak Plasma Concentration (Cmax) and Time to Peak Plasma Concentration (Tmax) of YN003
Zeitfenster: Up to 28 days of post initiation of last dose

Maximum observed plasma concentration (Cmax) and time to reach maximum observed plasma concentration (Tmax).
Up to 28 days of post initiation of last dose
Area Under the Plasma Concentration-Time Curve (AUC) of YN003
Zeitfenster: 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-∞).
Up to 28 days of post initiation of last dose
Terminal Half-life (t1/2), Clearance (CL), and Volume of Distribution (Vd) of YN003
Zeitfenster: Up to 28 days of post initiation of last dose

Terminal elimination half-life, total body clearance, and apparent volume of distribution.
Up to 28 days of post initiation of last dose
Overall Survival (OS)
Zeitfenster: From 1st dose to death from any cause, assessed at 6 and 12 months after first dose.

OS rates at 6 and 12 months.
From 1st dose to death from any cause, assessed at 6 and 12 months after first dose.
Progression-Free Survival (PFS)
Zeitfenster: 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.
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)
Zeitfenster: 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.
From first dose until disease progression or initiation of new antitumor therapy (estimated up to 2 years).
Duration of Response (DoR)
Zeitfenster: 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.
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)
Zeitfenster: 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.
From first dose until disease progression or initiation of new antitumor therapy (estimated up to 2 years).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Beijing Inno Medicine Co., Ltd.

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

27. Oktober 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

31. Dezember 2029

Studienanmeldedaten

Zuerst eingereicht

19. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. November 2026

Zuerst gepostet (Tatsächlich)

10. November 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

10. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • YN003-101
  • Beijing Inno Medicine Co., Ltd (Registrierungskennung: IND181709)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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