진행성 또는 전이성 고형 종양에서 HM16390의 용량 증량 및 확장 연구
진행성 또는 전이성 고형 종양 환자를 대상으로 한 HM16390의 1상, 오픈 라벨, 다기관, 용량 증량 및 확장 연구
This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent and in combination with pembrolizumab to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors.
Dose-Escalation Part is planned to establish the MTD or RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation Part, additional eligible subjects will be randomized 1:1 into each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the RDEs to be tested in the Dose-Expansion Part are determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent and in combination with pembrolizumab when administered at the RDEs to subjects in indication-specific expansion cohorts.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Hyebin Son
- 전화번호: 82-2-410-9835
- 이메일: hyebin.son@hanmi.co.kr
연구 장소
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Seoul, 대한민국, 03080
- 모병
- Seoul National University Hospital
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Seoul, 대한민국, 06351
- 모병
- Samsung Medical Center
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Seoul, 대한민국, 03722
- 모병
- Severance Hospital
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Seoul, 대한민국, 05505
- 모집하지 않고 적극적으로
- Asan Medical Center
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, 대한민국, 13620
- 모병
- Seoul National University Bundang Hospital
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California
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Los Angeles, California, 미국, 90095
- 모병
- The Regents of the University of California on behalf of its Los Angeles campus
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- 모병
- Massachusetts General Hospital
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Michigan
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Detroit, Michigan, 미국, 48201
- 모병
- Karmanos Cancer Institute
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Key Inclusion Criteria:
- Have a histologically and/or cytologically confirmed advanced or metastatic solid tumor and have failed or are intolerant to standard therapy with clinical benefit.
- Patients in the Dose-Escalation Part must have evaluable or measurable disease at baseline and the patients for Dose-Ranging and Dose-Expansion Part must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before allocation or randomization.
- Age of 18 years or older (or country's legal age of majority if the legal age was >18 years)
- Adequate renal function.
- Adequate hematologic function.
- Adequate liver function.
Key Exclusion Criteria:
- Received prior treatment with agent targeting the IL-2, IL-7, or IL-15 receptors, or related to mode of action of HM16390.
- Known active CNS metastases and/or carcinomatous meningitis.
- History of severe toxicities associated with a prior immunotherapy.
- Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per NCI-CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
- Has ongoing or suspected autoimmune disease.
- Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients.
- History of chronic liver disease or evidence of hepatic cirrhosis.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: HM16390
HM16390 Monotherapy |
HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle |
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실험적: HM16390 + pembrolizumab
HM16390 in combination with pembrolizumab |
Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
다른 이름들:
HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence and nature of DLTs
기간: At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
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To evaluate safety and tolerability of HM16390 as a single agent and in combination with pembrolizumab |
At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part
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Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0.
기간: Throughout the study until end of safety follow-up period (90 days after the last treatment)
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To evaluate safety and tolerability of HM16390 as a single agent, and in combination with pembrolizumab |
Throughout the study until end of safety follow-up period (90 days after the last treatment)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Objective response rate (ORR)
기간: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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Disease Control Rate (DCR)
기간: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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DCR will be measured as the proportion of subject with confirmed CR, PR, or Stable Disease (SD) as per RECIST v1.1 |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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The maximum serum concentration (Cmax)
기간: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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The time to reach Cmax (Tmax)
기간: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
기간: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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The AUC extrapolated to infinity (AUCinf)
기간: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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The AUC during the dosing interval (AUCtau)
기간: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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The serum concentration at the end of the dosing interval (Ctrough)
기간: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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The elimination half-life (T1/2)
기간: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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The apparent volume of distribution (Vd/F)
기간: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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The apparent clearance (CL/F)
기간: Throughout the study until treatment discontinuation (up to 2-3 years)
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To evaluate PK profile upon HM16390 administration |
Throughout the study until treatment discontinuation (up to 2-3 years)
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Progression-free survival (PFS)
기간: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v1.1 or until death from any cause, whichever occurs first |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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Duration of response (DOR)
기간: Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
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DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v1.1 or death from any cause, whichever occurs first. |
Throughout the study until disease progression or death whichever occurs first (up to 2-3 years)
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- HM-LIL2-101
- KEYNOTE-G39 (기타 식별자: Merck & Sharp Dohme LLC)
- MK-3475-G39 (기타 식별자: Merck & Sharp Dohme LLC)
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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