A Phase I Clinical Study of YN003 in the Treatment of Glioma
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
상태
정황
정황
개입 / 치료
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
연구 유형
등록 (추정된)
등록
단계
단계
- 1단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Kaiqi Zong, Master
- 전화번호: 13683178623
- 이메일: zongkaiqi@innovmedicine.com
연구 연락처 백업
- 이름: Yaqian Cui, Master
- 전화번호: 18811320289
- 이메일: cuiyaqian@innovmedicine.com
연구 장소
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California
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Los Angeles, California, 미국, 90095
- 아직 모집하지 않음
- University of California, Los Angeles (UCLA)
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연락하다:
- Timothy Cloughesy, Ph.D
- 이메일: John.deGroot@ucsf.edu
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San Francisco, California, 미국, 94158
- 아직 모집하지 않음
- University of California, San Francisco (UCSF)
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연락하다:
- Nazanin Majd, Ph.D
- 이메일: NKMajd@mdanderson.org
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Texas
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Houston, Texas, 미국, 77030
- 아직 모집하지 않음
- The University of Texas MD Anderson Cancer Center
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연락하다:
- Nazanin Majd, Ph.D
- 이메일: TCloughesy@mednet.ucla.edu
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 102218
- 모병
- Beijing Tsinghua Changgung Hospital
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연락하다:
- Xuejun Yang, Ph.D
- 전화번호: 13011329950
- 이메일: yxja03728@btch.edu.cn
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Beijing, Beijing Municipality, 중국
- 모병
- Sanbo Brain Hospital, Capital Medical University
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연락하다:
- Junping Zhang, Ph.D
- 전화번호: 13811099759
- 이메일: doczhjp@hotmail.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
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
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Study Drug： YN003 Injection
Single-arm, open-label study of YN003 administered by intravenous infusion once every 4 weeks. |
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
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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)
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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]
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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]
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak Plasma Concentration (Cmax) and Time to Peak Plasma Concentration (Tmax) of YN003
기간: Up to 28 days of post initiation of last dose
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Maximum observed plasma concentration (Cmax) and time to reach maximum observed plasma concentration (Tmax). |
Up to 28 days of post initiation of last dose
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Area Under the Plasma Concentration-Time Curve (AUC) of YN003
기간: Up to 28 days of post initiation of last dose
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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
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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
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Terminal elimination half-life, total body clearance, and apparent volume of distribution. |
Up to 28 days of post initiation of last dose
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Overall Survival (OS)
기간: From 1st dose to death from any cause, assessed at 6 and 12 months after first dose.
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OS rates at 6 and 12 months. |
From 1st dose to death from any cause, assessed at 6 and 12 months after first dose.
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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.
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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.
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Objective Response Rate (ORR)
기간: From first dose until disease progression or initiation of new antitumor therapy (estimated up to 2 years).
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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).
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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).
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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).
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Disease Control Rate (DCR)
기간: From first dose until disease progression or initiation of new antitumor therapy (estimated up to 2 years).
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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).
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
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
미국 FDA 규제 기기 제품 연구
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