- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05058352
A Study of HS269 in Patients With Advanced Solid Tumors
A Phase I, Open-label,Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS269, in Patients With Advanced Solid Tumor
연구 개요
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Wei Li
- 전화번호: 021-65115006
- 이메일: leewluck@gmail.com
연구 장소
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Shanghai, 중국
- Shanghai Pulmonary Hospital
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연락하다:
- Caicun Zhou
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- ≥18 years, no gender limit.
- Patients with advanced solid tumors confirmed by histology or cytology fail to receive standard treatment, or there is no standard treatment, or standard treatment is not applicable at this stage.
- At least one evaluable tumor lesion according to RECIST version 1.1.
- ECOG≤ 1.
- The estimated survival time was more than 3 months.
The function of all organs was good, the specific indexes were as follows:
Blood system (no transfusion or hematopoietic stimulating factor treatment within 14 days) i. #NEUT ≥1.5×109/L ii. PLT ≥90×109/L iii. HGB ≥85g/L Liver function i. TBIL ≤1.5×ULN ii. ALT ≤3×ULN; Patients with liver metastasis or liver cancer: ≤ 5 × ULN iii. AST ≤3×ULN; Patients with liver metastasis or liver cancer: ≤ 5 × ULN Renal function i. Ccr >50 ml/min(According to Cockcroft-Gault formula) Blood coagulation function i. APTT ≤1.5×ULN ii. INR ≤1.5×ULN
- The subjects should be informed and agreed to the study before the start of the trial, and sign the written informed consent voluntarily.
Exclusion Criteria:
- Received anti-tumor treatments within 14 days or less than 5 half-lives (whichever is longer) before the first use of the study drug
- Received blood transfusion, erythropoietin, recombinant human thrombopoietin or colony stimulating factor and other treatments within 7 days before receiving blood system examination during the screening period.
- Received other unmarketed clinical study drugs or treatments within 4 weeks before the first use of the study drug.
- Major organ surgery (excluding biopsy) or significant trauma occurred within 4 weeks before the first use of the study drug;
- Systemic administration of glucocorticoids (prednisone > 10 mg / day or equivalent dose of the same drug) or other immunosuppressants within 14 days before the first use of the study drug; except for local, eye, intra articular, nasal and inhaled corticosteroids; short-term use of glucocorticoids for preventive treatment (e.g. prevention of contrast agent allergy);
- CYP1A2/P-gp potent inhibitors or potent inducers were used within 7 days before the first use of the study drug;
- Resistance to selective RET inhibitors;
- The adverse reactions of previous anti-tumor therapy have not yet recovered to CTCAE 5.0 grade evaluation ≤ 1 (except for the toxicity without safety risk judged by researchers such as alopecia);
- Patients with central nervous system metastasis or meningeal metastasis with clinical symptoms, or other evidence indicating that the central nervous system metastasis or meningeal metastasis has not been controlled, which is not suitable for the study.
- Have active infection and need systemic anti infection therapy;
- Have a history of immunodeficiency, including HIV antibody test positive;
- Active hepatitis B, allowing preventive antiviral treatment other than interferon; hepatitis C virus infection;
- Present or past interstitial lung disease (except radiation-induced pulmonary fibrosis without hormone therapy);
- Poorly controlled diabetic patients.
Have a history of serious cardiovascular and cerebrovascular diseases, including but not limited to:
- Serious abnormal cardiac rhythm or conduction, such as ventricular arrhythmia, Ⅱ - Ⅲ degree atrioventricular block, etc;
- In the resting state, average QTcF≥480ms in 12 lead -ECG;
- Acute coronary syndrome, congestive heart failure, aortic dissection, stroke or other cardiovascular events of grade 3 or above occurred within 6 months before the first administration;
- NYHA ≥II or LVEF<50%;
- Hypertension beyond clinical control;
- Could not take medication orally,or have severe gastrointestinal obstruction (such as gastrointestinal obstruction, gastrointestinal absorption);
- The third space effusion, which could not be controlled clinically, was not suitable for the study;
- Mental disorder or poor compliance;
- Eligible patients with fertility (male and female) do not agree to use reliable contraceptive methods (abstinence, condom, intrauterine device or ligation) with their partner during the trial and for at least 3 months after the last medication.
- Female patients have a positive blood pregnancy test within 7 days before enrollment, or breastfeeding women;
- The subjects were not suitable for the clinical study because of other serious systemic diseases or other reasons according to the investigator 's judgment.
공부 계획
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 |
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실험적: HS269
Multiple doses of HS269 tablets
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Oral tablets, once daily.
Dose escalation from 50 mg QD, through 100 mg, 200mg, 300 mg, 400 mg, to 500mg.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Dose limiting toxicities (DLT)
기간: From date of initial dose until up to 33 days for treatment
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Incidence rate of dose limiting toxicities (DLT)
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From date of initial dose until up to 33 days for treatment
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Adverse Event(s) and Serious Adverse Event(s)
기간: Through study completion or early study discontinuation(up to 12 months)
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The occurrence and rate of AE and SAE
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Through study completion or early study discontinuation(up to 12 months)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Peak Plasma Concentration (Cmax)
기간: From date of initial dose until up to 33 days for treatment
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Cmax of HS269
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From date of initial dose until up to 33 days for treatment
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Area Under the Plasma Concentration versus Time Curve (AUC)
기간: From date of initial dose until up to 33 days for treatment
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AUC of HS269
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From date of initial dose until up to 33 days for treatment
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Calcitonin in Peripheral Blood
기간: Through study completion or early study discontinuation(up to 12 months)
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For Medullary Thyroid Cancer patients
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Through study completion or early study discontinuation(up to 12 months)
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Thyroglobulin in Peripheral Blood
기간: Through study completion or early study discontinuation(up to 12 months)
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For non-MTC thyroid cancer patients
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Through study completion or early study discontinuation(up to 12 months)
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ORR
기간: Approximately 12 months
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Objective response rate (ORR)
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Approximately 12 months
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DCR
기간: Approximately 12 months
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Disease control rate (DCR)
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Approximately 12 months
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PFS
기간: Approximately 12 months
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Progression free survival (PFS)
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Approximately 12 months
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Peripheral blood ctDNA
기간: Through study completion or early study discontinuation(up to 12 months)
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Only for patients with positive RET gene mutation
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Through study completion or early study discontinuation(up to 12 months)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Qiming Wang, Henan Provincial Cancer Hospital
- 수석 연구원: Qi Dang, Shandong Cancer Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- HS269-Ⅰ-01
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
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