Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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

4 november 2026 uppdaterad av: 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).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna, 90095
        • Har inte rekryterat ännu
        • University of California, Los Angeles (UCLA)
        • Kontakt:
      • San Francisco, California, Förenta staterna, 94158
        • Har inte rekryterat ännu
        • University of California, San Francisco (UCSF)
        • Kontakt:
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • Har inte rekryterat ännu
        • The University of Texas MD Anderson Cancer Center
        • Kontakt:
  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 102218
        • Rekrytering
        • Beijing Tsinghua Changgung Hospital
        • Kontakt:
      • Beijing, Beijing Municipality, Kina
        • Rekrytering
        • Sanbo Brain Hospital, Capital Medical University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Study Drug： YN003 Injection

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
To Incidence and characteristics of AEs/SAEs；
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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]

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Peak Plasma Concentration (Cmax) and Time to Peak Plasma Concentration (Tmax) of YN003
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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).

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Beijing Inno Medicine Co., Ltd.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

27 oktober 2026

Primärt slutförande (Beräknad)

31 december 2028

Avslutad studie (Beräknad)

31 december 2029

Studieregistreringsdatum

Först inskickad

19 oktober 2026

Först inskickad som uppfyllde QC-kriterierna

4 november 2026

Första postat (Faktisk)

10 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

10 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera