- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07567859
A Study of HS-10587 in Patients With Advanced Solid Tumors
2026년 4월 28일 업데이트: Jiangsu Hansoh Pharmaceutical Co., Ltd.
An Open-Label, Multi-Center Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Preliminary Efficacy of HS-10587 in Patients With Methylthioadenosine Phosphorylase (MTAP)-Deleted Advanced Solid Tumors
This is a Phase I, multicenter, open-label clinical trial with dose escalation/dose expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HS-10587 in patients with MTAP-deleted advanced solid tumors.
연구 개요
연구 유형
중재적
등록 (추정된)
362
단계
- 1단계
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
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Participants who voluntarily participate in this clinical study, understand the study procedures, and are able to sign a written ICF.
- Participants with locally advanced or recurrent metastatic malignant solid tumors confirmed by histopathology or cytopathology who have failed or are intolerant to at least one line of prior standard treatment, or for whom no standard treatment exists.
- Evidence of MTAP deletion in the tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥12 weeks.
- At least one measurable lesion that would qualify as target lesion by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1).
- Female participants of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed; male participants are willing to use barrier contraception.
Exclusion Criteria:
- History of other primary malignancies.
- Presence of pleural/abdominal effusion or pericardial effusion requiring clinical intervention.
- Presence of leptomeningeal metastasis, spinal cord compression, or brainstem metastasis; known untreated brain metastases, or symptomatic/unstable brain metastases.
- Participants who have any Grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 6.0) from prior anti-tumor therapies (except alopecia, pigmentation, and residual neurotoxicity).
- Inadequate bone marrow reserve or hepatic and renal functions.
- Severe, uncontrolled, or active cardiovascular diseases.
- Severe or poorly controlled diabetes.
- Severe or poorly controlled hypertension.
- Severe infection within 4 weeks prior to the first dose.
- Long-term corticosteroid therapy, history of other acquired/congenital immunodeficiency disorders, or organ transplantation.
- Known active infectious diseases.
- Clinically significant gastrointestinal dysfunction.
- Moderate to severe pulmonary diseases that seriously affect respiratory function.
- Prior history of severe neurological or mental disorders.
- Female participants who are pregnant or breastfeeding, or plan to become pregnant during the study.
- History of severe allergies, or history of hypersensitivity reactions to any active or inactive ingredients of HS-10587 or to drugs with similar chemical structures to HS-10587 or drugs of the same class as HS-10587.
- Participants with any conditions that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.
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: HS-10587 Monotherapy
Dose escalation cohorts and dose expansion cohorts of varying doses of HS-10587
|
HS-10587 tablet
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of DLT
기간: Up to 21 days after the first administration. (first cycle)
|
dose-limiting toxicities
|
Up to 21 days after the first administration. (first cycle)
|
|
MTD or MAD
기간: Up to 21 days after the first administration. (first cycle)
|
maximum tolerated dose (MTD) or maximum applicable dose (MAD)
|
Up to 21 days after the first administration. (first cycle)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of adverse events (AEs) and serious adverse events (SAEs)
기간: From time of informed consent to 28 days post last dose of HS-10587.
|
Number of participants with AEs and SAEs
|
From time of informed consent to 28 days post last dose of HS-10587.
|
|
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
기간: Predose and postdose up to end of treatment, approximately 2 years
|
Maximum concentration (Cmax).
|
Predose and postdose up to end of treatment, approximately 2 years
|
|
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
기간: Predose and postdose up to end of treatment, approximately 2 years.
|
Time of maximum concentration (Tmax).
|
Predose and postdose up to end of treatment, approximately 2 years.
|
|
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
기간: Predose and postdose up to end of treatment, approximately 2 years.
|
area under the plasma concentration-time curve from time 0 to time t of the last measurable concentration (AUC0-t)
|
Predose and postdose up to end of treatment, approximately 2 years.
|
|
Pharmacokinetics (PK) profile of HS-10587 in patients with advanced solid tumors
기간: Predose and postdose up to end of treatment, approximately 2 years
|
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-∞)
|
Predose and postdose up to end of treatment, approximately 2 years
|
|
Efficacy of HS-10587 in patients with advanced solid tumors
기간: Predose and post dose up to end of treatment, approximately 2 years
|
Objective response rate (ORR) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years
|
|
Efficacy of HS-10587 in patients with advanced solid tumors.
기간: Predose and post dose up to end of treatment, approximately 2 years.
|
Duration of response (DOR) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years.
|
|
Efficacy of HS-10587 in patients with advanced solid tumors.
기간: Predose and post dose up to end of treatment, approximately 2 years
|
Disease control rate (DCR) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years
|
|
Efficacy of HS-10587 in patients with advanced solid tumors.
기간: Predose and post dose up to end of treatment, approximately 2 years.
|
Time to response (TTR) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years.
|
|
Efficacy of HS-10587 in patients with advanced solid tumors.
기간: Predose and post dose up to end of treatment, approximately 2 years.
|
Progression-free survival (PFS) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years.
|
|
Efficacy of HS-10587 in patients with advanced solid tumors.
기간: Predose and post dose up to end of treatment, approximately 2 years
|
Overall survival (OS) evaluated as per RECIST v1.1
|
Predose and post dose up to end of treatment, approximately 2 years
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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 6월 4일
기본 완료 (추정된)
2027년 12월 31일
연구 완료 (추정된)
2028년 6월 30일
연구 등록 날짜
최초 제출
2026년 4월 20일
QC 기준을 충족하는 최초 제출
2026년 4월 28일
처음 게시됨 (실제)
2026년 5월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 4월 28일
마지막으로 확인됨
2026년 4월 1일
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- HS-10587-101
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. .