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

2026년 11월 4일 업데이트: 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).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

50

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • California
      • Los Angeles, California, 미국, 90095
        • 아직 모집하지 않음
        • University of California, Los Angeles (UCLA)
        • 연락하다:
      • San Francisco, California, 미국, 94158
        • 아직 모집하지 않음
        • University of California, San Francisco (UCSF)
        • 연락하다:
    • Texas
      • Houston, Texas, 미국, 77030
        • 아직 모집하지 않음
        • The University of Texas MD Anderson Cancer Center
        • 연락하다:
  • 중국
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 102218
        • 모병
        • Beijing Tsinghua Changgung Hospital
        • 연락하다:
      • Beijing, Beijing Municipality, 중국
        • 모병
        • Sanbo Brain Hospital, Capital Medical University
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Study Drug： YN003 Injection

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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
To Incidence and characteristics of AEs/SAEs；
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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]

2차 결과 측정

결과 측정
측정값 설명
기간
Peak Plasma Concentration (Cmax) and Time to Peak Plasma Concentration (Tmax) of YN003
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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).

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beijing Inno Medicine Co., Ltd.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 10월 27일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2029년 12월 31일

연구 등록 날짜

최초 제출

2026년 10월 19일

QC 기준을 충족하는 최초 제출

2026년 11월 4일

처음 게시됨 (실제)

2026년 11월 10일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 10일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 11월 4일

마지막으로 확인됨

2026년 11월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다