HMPL-306 tablet의 IDH1 또는 IDH2 돌연변이를 가진 2등급 성상세포종 또는 희소돌기아교종 - 임상 시험 레지스트리

연구 개요

상태

아직 모집하지 않음

정황

IDH1 또는 IDH2 돌연변이를 가진 2등급 성상세포종 또는 희소돌기아교종

개입 / 치료

상세 설명

This study plans to enroll approximately 210 participants with postoperative residual or recurrent grade 2 astrocytoma or oligodendroglioma carrying IDH1 or IDH2 mutations who have previously received only surgical treatment.

Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 250 mg or placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.

Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.

연구 유형

중재적

등록 (추정된)

210

단계

3단계

연락처 및 위치

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

연구 연락처

이름: Lu Chen
전화번호: 021 -2067 3000 - 5014
이메일: Luc@hutch-med.com

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

Have fully understood this study and voluntarily signed the ICF, willing to complete the planned visits, treatments, procedures, and laboratory tests during the study period;
Age ≥18 years old;
Patients with grade 2 oligodendroglioma or grade 2 astrocytoma;
Have confirmed presence of IDH1 or IDH2 gene mutation, and obtained chromosome 1p/19q status;
Have undergone at least 1 glioma surgery and have not received any other anti-glioma treatments, including chemotherapy and radiotherapy;
Confirmed by BIRC, at least 1 measurable non-enhancing lesion meeting RANO 2.0 criteria using two-dimensional magnetic resonance imaging (MRI) measurement at screening;
KPS ≥80;
As judged by the investigator, life expectancy of ≥12 months;
Adequate bone marrow, hepatic, renal, and coagulation function

Exclusion Criteria:

Previously received any other anti-glioma treatment except for surgery, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or biological therapy, etc.;
Participants assessed by the investigator as having high-risk factors, including but not limited to tumor involvement of the brainstem, or uncontrolled epilepsy;
Participants with concurrent other malignant tumors or a history of other malignant tumors within 5 years prior to randomization (excluding cured basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and ductal carcinoma in situ of the breast, etc.);
Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
Known allergy to any component of HMPL-306;
Administration of uridine diphosphate glucuronosyltransferase (UGT) 1A1 inhibitors or UGT1A3 inhibitors less than 1 week or 5 half-lives (whichever is longer) prior to randomization; administration of strong inducers of CYP3A less than 2 weeks or 5 half-lives (whichever is longer) prior to randomization;
Presence of diseases or conditions that affect drug absorption;
Participants will be excluded if there is any other disease, mental abnormality, metabolic abnormality, physical examination abnormality, or laboratory parameter abnormality of significant clinical significance, etc., which, in the investigator's judgment, may affect the participant's compliance, or place the participant at high risk, or affect the interpretation of study results, or if there is reason to suspect that the participant has a disease or condition unsuitable for the use of the study drug.

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: 무작위
중재 모델: 병렬 할당
마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔 참가자 그룹 / 팔 시험 프로토콜에 따라 특정 중재/치료를 받거나 중재를 받지 않는 임상 시험 참가자 그룹 또는 하위 그룹입니다.	개입 / 치료 개입 / 치료 임상 연구의 초점이 되는 프로세스 또는 작업입니다. 개입에는 약물, 의료 기기, 절차, 백신 및 조사 중이거나 이미 사용 가능한 기타 제품이 포함됩니다. 개입에는 교육이나 식이요법 및 운동 수정과 같은 비침습적 접근법도 포함될 수 있습니다.
실험적: HMPL-306 tablet Participants in HMPL-306 group will receive HMPL-306 250 mg administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.	의약품: HMPL-306 tablet Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in HMPL-306 group will receive HMPL-306 250 mg administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.
위약 비교기: Placebo Participants in placebo group will receive placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first. Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.	의약품: Placebo Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in placebo group will receive placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first. Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.

참가자 그룹 / 팔

개입 / 치료

실험적: HMPL-306 tablet

Participants in HMPL-306 group will receive HMPL-306 250 mg administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.

의약품: HMPL-306 tablet

Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in HMPL-306 group will receive HMPL-306 250 mg administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.

위약 비교기: Placebo

Participants in placebo group will receive placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.

Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.

의약품: Placebo

Participants meeting all enrollment eligibility criteria will be randomized in a 1:1 ratio to receive HMPL-306 or placebo matched to HMPL-306 administered orally once daily (QD). Participants in placebo group will receive placebo matched to HMPL-306 administered orally once daily (QD). Participants will continue to receive study drug treatment in 28-day cycles until BIRC-confirmed PD, death, occurrence of intolerable toxicity, et al, whichever occurs first.

Participants in the placebo group with BIRC-confirmed PD, after evaluation, may cross over to the HMPL-306 group to receive HMPL-306 treatment.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
PFS assessed by BIRC (according to Response Assessment in Neuro-Oncology [RANO] 2.0 criteria) 기간: Up to approximately 30 months	PFS(progression-free survival ):The time from the date of randomization to the date of first disease progression (PD) confirmed by BIRC(Blinded Independent Review Committee) or death from any cause	Up to approximately 30 months

2차 결과 측정

결과 측정	측정값 설명	기간
TTNI 기간: Up to approximately 36 months	TTNI(time to next intervention ):The time from the date of randomization to the date of first initiation of any subsequent anti-tumor therapy or all-cause death	Up to approximately 36 months
TGR 기간: every 6months,up to approximately 30 months	TGR( tumor growth rate) :The time from the date of randomization to the date of first disease progression (PD) confirmed by BIRC or death from any cause	every 6months,up to approximately 30 months
TEAEs 기간: Up to approximately 30 months	Treatment-emergent adverse events (TEAEs) are defined as all adverse medical events that occur after participants receive the investigational medicinal product, which may manifest as symptoms, signs, diseases, or laboratory abnormalities, but are not necessarily causally related to the investigational medicinal product.	Up to approximately 30 months
PFS assessed by Investigator 기간: Up to approximately 30 months	PFS ( progression-free survival) : the time from the date of randomization to the date of first PD confirmed by investigators or all-cause death	Up to approximately 30 months
ORR 기간: Up to approximately 30 months	ORR(objective response rate),defined as the proportion of participants with best overall response of complete response (CR), partial response (PR), and minor response (MR)	Up to approximately 30 months
DCR 기간: Up to approximately 30 months	DCR(disease control rate), defined as the proportion of participants with best overall response of CR(complete response), PR(partial response), MR(minor response), and SD(Stable Disease )	Up to approximately 30 months
TTR 기간: Up to approximately 30 months	TTR(the time to response), defined as the time from the date of randomization to the date of first documented CR(complete response), PR(partial response), MR(minor response)	Up to approximately 30 months
DoR 기간: Up to approximately 30 months	DoR( duration of response), defined as the time from the date of first documented CR(complete response), PR(partial response), MR(minor response) to the date of first documented PD(Disease Progression) or death	Up to approximately 30 months
(CR+PR) Rate 기간: Up to approximately 30 months	CR+PR rate(the proportion of complete response and partial response), defined as the proportion of participants with best overall response of CR(complete response), and PR(partial response)	Up to approximately 30 months
Time to CR+PR 기간: Up to approximately 30 months	Time to CR+PR, defined as the time from the date of randomization to the date of first documented CR(complete response), or PR(partial response)	Up to approximately 30 months
Duration of CR+PR 기간: Up to approximately 30 months	Duration of CR+PR, defined as the time from the date of first documented CR or PR to the date of first documented PD or death from any cause, whichever occurs first	Up to approximately 30 months
OS 기간: Up to approximately 30 months	Overall survival (OS) :the time from the date of randomization to the date of all-cause death	Up to approximately 30 months
HRQoL (health-related quality of life)assessed by the FACT-Br (Functional Assessment of Cancer Therapy-Brain)questionnaire 기간: Up to approximately 30 months	The health-related quality of life (HRQoL) will be evaluated using the Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire in participants treated with HMPL-306 versus placebo	Up to approximately 30 months
PK characteristics(plasma drug concentrations at each sampling time point) 기간: Up to approximately 6 months	Plasma drug concentrations at each sampling time point	Up to approximately 6 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hutchmed

수사관

수석 연구원: Jinsong Wu, MD, Huashan Hospital

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 (추정된)

2026년 11월 1일

기본 완료 (추정된)

2032년 3월 1일

연구 완료 (추정된)

2032년 9월 1일

연구 등록 날짜

최초 제출

2026년 10월 19일

QC 기준을 충족하는 최초 제출

2026년 10월 27일

처음 게시됨 (실제)

2026년 11월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 27일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

2026-306-00CH1

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

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. .

HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HMPL-306 in Participants With Postoperative Residual or Recurrent Grade 2 Glioma Harboring IDH1 or IDH2 Mutations

연구 개요

상태

정황

개입 / 치료

상세 설명

연구 유형

등록 (추정된)

단계

연락처 및 위치

연구 연락처

참여기준

자격 기준

공부할 수 있는 나이

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

설명

공부 계획

연구는 어떻게 설계됩니까?

디자인 세부사항

팔의 수

무기와 개입

참가자 그룹 / 팔

개입 / 치료

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정

측정값 설명

기간

2차 결과 측정

결과 측정

측정값 설명

기간

공동 작업자 및 조사자

스폰서

수사관

연구 기록 날짜

연구 주요 날짜

연구 시작 (추정된)

기본 완료 (추정된)

연구 완료 (추정된)

연구 등록 날짜

최초 제출

QC 기준을 충족하는 최초 제출

처음 게시됨 (실제)

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

QC 기준을 충족하는 마지막 업데이트 제출

마지막으로 확인됨

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

미국 FDA 규제 기기 제품 연구